The following data is part of a De Novo classification by Phadia Us Inc. with the FDA for Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-tryptase.
| DeNovo ID | DEN120001 |
| Device Name: | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE |
| Classification | Tryptase Assay System |
| Applicant | PHADIA US INC. 4169 Commercial Ave. Portage, MI 49002 |
| Contact | Martin Mann |
| Product Code | OYL |
| CFR Regulation Number | 866.5760 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K103039 |
| Review Advisory Board | Immunology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2012-01-12 |
| Decision Date | 2012-02-15 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066000275 | DEN120001 | 000 |
| 07333066000312 | DEN120001 | 000 |
| 07333066000251 | DEN120001 | 000 |
| 07333066004082 | DEN120001 | 000 |
| 07333066000350 | DEN120001 | 000 |