The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Ck-nac Reagent Creatine Kinase N-acetyl Cysteine.
| Device ID | K860733 |
| 510k Number | K860733 |
| Device Name: | CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | W. C Riddle |
| Correspondent | W. C Riddle TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-26 |
| Decision Date | 1986-04-24 |