The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Dart Alt (gpt) Reagent.
| Device ID | K905767 |
| 510k Number | K905767 |
| Device Name: | COULTER DART ALT (GPT) REAGENT |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-01-25 |