ARBOVIRUS IGG IFA TEST
FDA 510(k) clearance K913617 · decided 1992-12-03
Clearance details
- K-number
- K913617
- Device name
- ARBOVIRUS IGG IFA TEST
- Applicant
- Hillcrest Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1991-08-13
- Decision date
- 1992-12-03
- Days to decision
- 478 days
- Clearance type
- Traditional
- Product code
- GQC
- Device class
- 1
- Regulation number
- 866.3240
- 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 |
|---|---|---|
| ARBOVIRUS IGM IFA TEST (K913618) | Hillcrest Biologicals | 1992-12-03 |
Recalls involving this device
No recalls on record reference this clearance.