FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
FDA 510(k) clearance K812013 · decided 1981-07-28
Clearance details
- K-number
- K812013
- Device name
- FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
- Applicant
- Springwood Microbiologicals
- Decision
- Substantially Equivalent
- Date received
- 1981-07-17
- Decision date
- 1981-07-28
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- GTX
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 B POLYVALENT FLUORO-KIT (K801876) | Clinical Sciences, Inc. | 1980-09-16 |
Recalls involving this device
No recalls on record reference this clearance.