|
Device | HAVAB-M EIA DIAGNOSTIC KIT |
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 | S007 |
Date Received | 11/25/1994 |
Decision Date | 05/29/1996 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO EXTEND EXPIRATION DATING TO 8 MONTHS FROM THE DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUS |