The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Ast Reagent (procedure Number 158).
| Device ID | K892844 |
| 510k Number | K892844 |
| Device Name: | AST REAGENT (PROCEDURE NUMBER 158) |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-18 |
| Decision Date | 1989-06-20 |