STREP D FLUOR
FDA 510(k) clearance K860041 · decided 1986-01-24
Clearance details
- K-number
- K860041
- Device name
- STREP D FLUOR
- Applicant
- Bio Spec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-06
- Decision date
- 1986-01-24
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- GTP
- Device class
- 1
- Regulation number
- 866.3720
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Concord, 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 |
|---|---|---|
| LEAP STREP TEST KIT (K833738) | Cooper Biomedical, Inc. | 1983-12-27 |
| STREPTACOCCUS CO-AGGLUTINATION KIT (K822799) | American Scientific Products | 1982-12-19 |
Recalls involving this device
No recalls on record reference this clearance.