The following data is part of a premarket notification filed by General Diagnostics with the FDA for Chem-strate Ck-nac.
| Device ID | K792477 |
| 510k Number | K792477 |
| Device Name: | CHEM-STRATE CK-NAC |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-03 |
| Decision Date | 1979-12-27 |