Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ETI-HA-IGMK |
Generic Name | Hepatitis a test (antibody and igm antibody) |
Regulation Number | 866.3310 |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. STILLWATER, MN 55082-0285 |
PMA Number | P890014 |
Supplement Number | S001 |
Date Received | 11/23/1990 |
Decision Date | 09/16/1991 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
|
|