QUIDEL CH50 EQ EIA
FDA 510(k) clearance K974111 · decided 1998-07-29
Clearance details
- K-number
- K974111
- Device name
- QUIDEL CH50 EQ EIA
- Applicant
- Quidel Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-31
- Decision date
- 1998-07-29
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- DAE
- Device class
- 2
- Regulation number
- 866.5240
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| WAKO AUTOKIT CH50 (K954145) | Wako Chemicals USA, Inc. | 1995-12-18 |
| COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) (K951639) | Incstar Corp. | 1995-10-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| QUS-2 CALCANEAL ULTRASONOMETER (P990039/S001) | Quidel Corp. | 2003-06-19 |
| QUS-2 (TM) CALCANEAL ULTRASONOMETER (P990039) | Quidel Corp. | 2000-08-01 |