The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Alt (gpt) - Alanine Aminotransferase.
| Device ID | K923510 |
| 510k Number | K923510 |
| Device Name: | ALT (GPT) - ALANINE AMINOTRANSFERASE |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| 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 |
|---|---|---|
| 05055273200225 | K923510 | 000 |
| 05055273200218 | K923510 | 000 |
| 05055273200188 | K923510 | 000 |
| 05055273200164 | K923510 | 000 |
| 05055273200157 | K923510 | 000 |
| 05055273200133 | K923510 | 000 |
| 05055273200249 | K923510 | 000 |
| 05055273200232 | K923510 | 000 |
| 05055273200195 | K923510 | 000 |