510(k) DEN120001
DEN120001 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE". The FDA issued a decision of De Novo Granted on February 15, 2012. The device falls under product code OYL (Tryptase Assay System), a Class II device regulated under 21 CFR 866.5760. Phadia US, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 15, 2012
- Date Received
- January 12, 2012
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tryptase Assay System
- Device Class
- Class II
- Regulation Number
- 866.5760
- Review Panel
- IM
- Submission Type
An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.