IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
FDA 510(k) clearance K133404 · decided 2014-02-24
Clearance details
- K-number
- K133404
- Device name
- IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
- Applicant
- Phadia AB
- Decision
- Substantially Equivalent
- Date received
- 2013-11-06
- Decision date
- 2014-02-24
- Days to decision
- 110 days
- Clearance type
- Special
- Product code
- DGC
- Device class
- 2
- Regulation number
- 866.5510
- 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
| Record | Firm | Date |
|---|---|---|
| Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instru recall (Z-0947-2015) | Phadia US Inc | 2015-01-12 |