MICROBIO. PROD. FLUORESCENT ANTIBODY
FDA 510(k) clearance K770801 · decided 1977-05-25
Clearance details
- K-number
- K770801
- Device name
- MICROBIO. PROD. FLUORESCENT ANTIBODY
- Applicant
- Pfizer Pharmaceuticals
- Decision
- Substantially Equivalent
- Date received
- 1977-05-02
- Decision date
- 1977-05-25
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- GMY
- Device class
- 1
- Regulation number
- 866.3255
- 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 |
|---|---|---|
| FLUORETEC-M (K770833) | Pfizer, Inc. | 1977-06-08 |
Recalls involving this device
No recalls on record reference this clearance.