The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Ck-mb (nac-act).
| Device ID | K951223 |
| 510k Number | K951223 |
| Device Name: | CK-MB (NAC-ACT) |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1995-12-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273201444 | K951223 | 000 |
| 05055273201420 | K951223 | 000 |
| 05055273201413 | K951223 | 000 |