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 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
Generic Name | CYCLOSPORINE |
Regulation Number | 862.1235 |
Applicant | DADE BEHRING, INC. PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P920031 |
Supplement Number | S001 |
Date Received | 07/02/1999 |
Decision Date | 08/11/2000 |
Reclassified Date
|
10/16/2002 |
Product Code |
MKW |
Advisory Committee |
Toxicology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EMIT(R) CYCLOSPORINE SAMPLE PRETREATMENT REAGENT AND COBAS INTEGRA 700 CYCLOSPORINE. |
|
|