ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
FDA 510(k) clearance K173704 · decided 2018-03-02
Clearance details
- K-number
- K173704
- Device name
- ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
- Applicant
- Phadia AB
- Decision
- Substantially Equivalent
- Date received
- 2017-12-04
- Decision date
- 2018-03-02
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- OYL
- Device class
- 2
- Regulation number
- 866.5760
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE (DEN120001) | Phadia US, Inc. | 2012-02-15 |
Recalls involving this device
No recalls on record reference this clearance.