|
Device | ABBOTT IMX(R) HAVAB(R)-M |
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 | S010 |
Date Received | 06/20/1997 |
Decision Date | 07/24/1997 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE EVALUATION OF THE HAVAB-M EIA CONJUGATE CONCENTRATE, POSITIVE CONTROL FROM A SAMPLE TO STANDARD RATIO TO A SAMPLE TO TARGET RATIO. |