Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device mixture, hematology quality control
Product CodeJPK
Regulation Number 864.8625
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 5
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
R & D SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRECK
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2014 1 1
2019 1 1
2020 1 1
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Coagulation in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Eye Injury 1 1
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton, Dickinson and Company, BD Biosciences II Dec-10-2020
2 Clinical Diagnostic Solutions II Apr-09-2014
3 Clinical Diagnostic Solutions III Nov-05-2012
4 Clinical Diagnostic Solutions III Nov-02-2012
5 Horiba Instruments, Inc dba Horiba Medical III Nov-21-2012
6 Medline Industries Inc II Mar-12-2021
7 Primus Corporation dba Trinity Biotech III Dec-01-2022
8 Quantimetrix Corporation II Jan-17-2009
9 R & D Systems, Inc. III Jan-19-2023
-
-