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 | K864359 |
| 510k Number | K864359 |
| 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 | William C Riddle |
| Correspondent | William 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 | 1986-11-03 |
| Decision Date | 1987-02-06 |