CENTRIA RADIOIMMUNOASSAY SEPARATION
FDA 510(k) clearance K792636 · decided 1980-01-11
Clearance details
- K-number
- K792636
- Device name
- CENTRIA RADIOIMMUNOASSAY SEPARATION
- Applicant
- Union Carbide Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-20
- Decision date
- 1980-01-11
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- KTS
- Device class
- 2
- Regulation number
- 866.5510
- 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 |
|---|---|---|
| SAC-CEL (K813508) | Burroughs Wellcome Co. | 1981-12-29 |
| CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) (K792637) | Union Carbide Corp. | 1980-01-11 |
| SECOND ANTIBODY (K781070) | Pcl-Ria, Inc. | 1978-08-10 |
Recalls involving this device
No recalls on record reference this clearance.