The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Ck-nac Activated Kit.
| Device ID | K923511 |
| 510k Number | K923511 |
| Device Name: | CK-NAC ACTIVATED KIT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| 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 | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1992-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273201581 | K923511 | 000 |
| 05055273201543 | K923511 | 000 |
| 05055273201505 | K923511 | 000 |
| 05055273201482 | K923511 | 000 |
| 05055273201475 | K923511 | 000 |
| 05055273201468 | K923511 | 000 |
| 05055273201406 | K923511 | 000 |
| 05055273201390 | K923511 | 000 |