The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Dart Ast (got) Reagent.
| Device ID | K905771 |
| 510k Number | K905771 |
| Device Name: | COULTER DART AST (GOT) REAGENT |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | Richardson Jones |
| Correspondent | Richardson Jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-02-26 |