GOAT ANTI-HUMAN KAPPA AFFINITY
FDA 510(k) clearance K832260 · decided 1983-10-31
Clearance details
- K-number
- K832260
- Device name
- GOAT ANTI-HUMAN KAPPA AFFINITY
- Applicant
- Gelco Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-30
- Decision date
- 1983-10-31
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- DEO
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| RABBIT ANTISERUM TO HUMAN KAPPA LIGHT (K831904) | Dako Corp. | 1983-07-19 |
Recalls involving this device
No recalls on record reference this clearance.