The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Centrifi Chem Ast/sgot.
| Device ID | K800641 |
| 510k Number | K800641 |
| Device Name: | CENTRIFI CHEM AST/SGOT |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-24 |
| Decision Date | 1980-04-10 |