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

Premarket Approval (PMA)
  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHAVAB-M DIAGNOSTIC KIT
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantAbbott Laboratories
D-49C, BUILDING AP6C
100 ABBOTT PARK ROAD
ABBOTT PARK NORTH, IL 60064-3500
PMA NumberP790019
Supplement NumberS006
Date Received11/25/1994
Decision Date05/29/1996
Reclassified Date 02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO EXTEND EXPIRATION DATING TO 70DAYS FROM THE DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUS
-
-