|
Device | HAVAB-M (R) EIA |
Generic Name | Hepatitis a test (antibody and igm antibody) |
Regulation Number | 866.3310 |
Applicant | Abbott Laboratories D-49C, BUILDING AP6C 100 ABBOTT PARK ROAD ABBOTT PARK NORTH, IL 60064-3500 |
PMA Number | P790019 |
Supplement Number | S012 |
Date Received | 10/03/2001 |
Decision Date | 09/05/2002 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD ADDITIONAL TESTING TO THE HAVAB-M EIA MASTERLOT TO PROVIDE A QUALITY CHECK OF THE FINAL PACKAGED KIT. |