STREPTACOCCUS CO-AGGLUTINATION KIT
FDA 510(k) clearance K822799 · decided 1982-12-19
Clearance details
- K-number
- K822799
- Device name
- STREPTACOCCUS CO-AGGLUTINATION KIT
- Applicant
- American Scientific Products
- Decision
- Substantially Equivalent
- Date received
- 1982-09-16
- Decision date
- 1982-12-19
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- GTP
- Device class
- 1
- Regulation number
- 866.3720
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, 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 |
|---|---|---|
| STREP D FLUOR (K860041) | Bio Spec, Inc. | 1986-01-24 |
| LEAP STREP TEST KIT (K833738) | Cooper Biomedical, Inc. | 1983-12-27 |
Recalls involving this device
No recalls on record reference this clearance.