510(k) K173704
K173704 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip". The FDA issued a decision of Substantially Equivalent on March 2, 2018. The device falls under product code OYL (Tryptase Assay System), a Class II device regulated under 21 CFR 866.5760. Phadia AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2018
- Date Received
- December 4, 2017
- Clearance Type
- Traditional
- 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.