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 Hemoglobin A1c Test System
510(k) Number K130255
Device Name HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3502
Applicant Contact JUDITH R WALLACH
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3502
Correspondent Contact JUDITH R WALLACH
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Codes
JIT   JJX   LCP  
Date Received02/01/2013
Decision Date 02/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-