The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Creatine Kinase Reagent Ck Lts.
| Device ID | K831965 |
| 510k Number | K831965 |
| Device Name: | CREATINE KINASE REAGENT CK LTS |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-20 |
| Decision Date | 1983-09-12 |