The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Ast (got) Ifcc 2-vial Reagent W/pyridoxyl Phosphat.
| Device ID | K891468 |
| 510k Number | K891468 |
| Device Name: | AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | P. J Ruthven |
| Correspondent | P. J Ruthven TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-15 |
| Decision Date | 1989-05-22 |