The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Creatine Kinase Reagent System.
| Device ID | K952745 |
| 510k Number | K952745 |
| Device Name: | CREATINE KINASE REAGENT SYSTEM |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Contact | Michael D Bick |
| Correspondent | Michael D Bick MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-16 |
| Decision Date | 1995-08-11 |