The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Ast (got) - Aspartate Aminotransferase.
| Device ID | K923505 |
| 510k Number | K923505 |
| Device Name: | AST (GOT) - ASPARTATE AMINOTRANSFERASE |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1992-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200508 | K923505 | 000 |
| 05055273200492 | K923505 | 000 |
| 05055273200485 | K923505 | 000 |
| 05055273200478 | K923505 | 000 |
| 05055273200461 | K923505 | 000 |
| 05055273200454 | K923505 | 000 |
| 05055273200430 | K923505 | 000 |
| 05055273200423 | K923505 | 000 |
| 05055273200416 | K923505 | 000 |