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 | MATRITECH NMP22(TM) TEST KIT |
Applicant | Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 |
PMA Number | P940035 |
Supplement Number | S001 |
Date Received | 12/16/1996 |
Decision Date | 03/19/1997 |
Advisory Committee |
Immunology |
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 THE CHANGE IN SPECIMEN COLLECTION TO A SINGLE VOID OF URINE, COLLECTED BETWEEN MIDNIGHT AND NOON, WHICH WILL BE TESTED USING THE MATRITECH NMP22(R) TEST KIT. |
|
|