|
Device | ABBOTT IMX HAVAB-M LIST 2263 |
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 | S020 |
Date Received | 09/14/2005 |
Decision Date | 10/06/2005 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, IMPLEMENTED TO IMPROVE MANUFACTURABILITY WITHOUT COMPROMISING PRODUCT PERFORMANCE. |