Current List of FDA-Recognized 510(k) Third Party Review Organizations

Database updated April 22, 2024

This page provides information on organizations recognized by FDA to review submissions under the 510(k) Third Party Review Program (formally, the Accredited Persons Program) and the devices they may review. Product codes eligible to review by a specific 3P510k Review Organization are listed under the following regulations. Devices eligible for review by 3P510k Review Organizations are limited to the product codes shown on the list of eligible devices. You can look up a given product code in the product code database, browse by 3P510k review organization in the list below or browse by device area to confirm eligibility of your device.

As of August 13, 2021, Accelerated Device Approval Services, LLC (ADAS) is no longer recognized to conduct 510(k) Third Party Reviews. For details, see the Accreditation Status section on the 510(k) Third Party Performance Metrics and Accreditation Status page.

AABB	BeanStock Consulting
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL	COLA, Inc.
Global Quality and Regulatory Services	REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC

AABB

4550 Montgomery Road, North Tower Suite 700

Bethesda MD 20814    

contact:	Melanie Sloan
phone:	1 301 2156540

Panel

Section Number

       Regulation Name / Device Name      

Class

Clinical Chemistry

862.1475

Lipoprotein test system.

I

862.1675

Blood specimen collection device.

II

862.2050

General purpose laboratory equipment labeled or promoted for a specific medical use.

I

Panel

Section Number

       Regulation Name / Device Name      

Class

Cardiovascular

870.1120

Blood pressure cuff.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

Hematology

864.5200

Automated cell counter.

II

864.5220

Automated differential cell counter.

II

864.5260

Automated cell-locating device.

II

864.5300

Red cell indices device.

II

864.5400

Coagulation instrument.

II

864.5425

Multipurpose system for in vitro coagulation studies.

II

864.5700

Automated platelet aggregation system.

II

864.5950

Blood volume measuring device.

II

864.6550

Occult blood test.

II

864.6675

Platelet aggregometer.

II

864.7140

Activated whole blood clotting time tests.

II

864.7320

Fibrinogen/fibrin degradation products assay.

II

864.7340

Fibrinogen determination system.

II

864.7415

Abnormal hemoglobin assay.

II

864.7425

Carboxyhemoglobin assay.

II

864.7455

Fetal hemoglobin assay.

II

864.7500

Whole blood hemoglobin assays.

II

864.7525

Heparin assay.

II

864.7750

Prothrombin time test.

II

864.7825

Sickle cell test.

II

864.7875

Thrombin time test.

II

864.7925

Partial thromboplastin time tests.

II

864.9650

Quality control kit for blood banking reagents.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

General Hospital

880.2800

Sterilization process indicator.

II

880.2910

Clinical electronic thermometer.

II

880.5440

Intravascular administration set.

II

880.5570

Hypodermic single lumen needle.

II

880.6250

Non-powdered patient examination glove.

I

880.6850

Sterilization wrap.

II

880.6870

Dry-heat sterilizer.

II

880.6880

Steam sterilizer.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

Microbiology

866.1620

Antimicrobial susceptibility test disc.

II

866.1700

Culture medium for antimicrobial susceptibility tests.

II

866.2390

Transport culture medium.

I

866.2560

Microbial growth monitor.

I

866.2900

Microbiological specimen collection and transport device.

I

866.3175

Cytomegalovirus serological reagents.

II

866.3480

Respiratory syncytial virus serological reagents.

I

866.3820

Treponema pallidum nontreponemal test reagents.

II

866.3830

Treponema pallidum treponemal test reagents.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

General & Plastic Surgery

878.4040

Surgical apparel.

II