FLUORESCENT ANTI. ANTI-HUMAN C3
FDA 510(k) clearance K771583 · decided 1977-09-02
Clearance details
- K-number
- K771583
- Device name
- FLUORESCENT ANTI. ANTI-HUMAN C3
- Applicant
- Burroughs Wellcome Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-18
- Decision date
- 1977-09-02
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DAC
- Device class
- 2
- Regulation number
- 866.5260
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| EZ COMPLEMENT C1 (K891904) | Diamedix Corp. | 1989-04-14 |
Recalls involving this device
No recalls on record reference this clearance.