The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Centria Radioimmunoassay Separation.
| Device ID | K792636 |
| 510k Number | K792636 |
| Device Name: | CENTRIA RADIOIMMUNOASSAY SEPARATION |
| Classification | Second Antibody (species Specific Anti-animal Gamma Globulin) |
| Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTS |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-20 |
| Decision Date | 1980-01-11 |