IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
FDA 510(k) clearance DEN120001 · decided 2012-02-15
Clearance details
- K-number
- DEN120001
- Device name
- IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
- Applicant
- Phadia US, Inc.
- Decision
- Unknown
- Date received
- 2012-01-12
- Decision date
- 2012-02-15
- Days to decision
- 34 days
- Clearance type
- Post-NSE
- Product code
- OYL
- Device class
- 2
- Regulation number
- 866.5760
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Portage, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.