• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name hepatitis a test (antibody and igm antibody)
510(k) Number K113704
Device Name ARCHITECT HAVAB-G
Original Applicant
ABBOTT LABORATORIES
100 abbott park rd.
dept. 09va, bldg. ap5 north
abbott park,  IL  60064 6092
Original Contact judith wallach
Regulation Number866.3310
Classification Product Code
LOL  
Subsequent Product Codes
JIS   MJX   MJY  
Date Received12/16/2011
Decision Date 06/28/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-