Device Classification Name |
tryptase assay system
|
De Novo Number |
DEN120001 |
510(K) Number |
K103039
|
Device Name |
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE |
Requester |
phadia us inc. |
4169 commercial ave. |
portage,
MI
49002
|
|
Contact |
martin mann |
|
Regulation Number | 866.5760
|
Classification Product Code |
|
Date Received | 01/12/2012 |
Decision Date | 02/15/2012 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Immunology
|
Review Advisory Committee |
Immunology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|