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

510(k) Premarket Notification
  • 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 Back To Search Results
Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K163629
Device Name Audit MicroControls Linearity FD Tumor Markers II
Applicant
Aalto Scientific, Ltd.
230 Technology Pkwy.
Eatonton,  GA  31024
Applicant Contact Robert Burda
Correspondent
Aalto Scientific, Ltd.
230 Technology Pkwy.
Eatonton,  GA  31024
Correspondent Contact Robert Burda
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/22/2016
Decision Date 03/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-