Q FEVER IGM IFA TEST
FDA 510(k) clearance K922374 · decided 1992-10-21
Clearance details
- K-number
- K922374
- Device name
- Q FEVER IGM IFA TEST
- Applicant
- Hillcrest Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1992-05-20
- Decision date
- 1992-10-21
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- GPJ
- Device class
- 1
- Regulation number
- 866.3500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- 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 |
|---|---|---|
| Q FEVER IGG IFA TEST (K913906) | Hillcrest Biologicals | 1992-10-21 |
Recalls involving this device
No recalls on record reference this clearance.