|
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 | S008 |
Date Received | 01/31/1997 |
Decision Date | 03/27/1997 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE REFERENCE PANEL, TO REMOVE THE IGM ANTI-HBC POSITIVE PLASMA AND THE RHEUMATOID FACTOR POSITIVE PLASMA MIXED WITH HIGH TITER ANTI-HAV IGG POSITIVE PLASMA |