The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Nml Ck-mb Ria.
| Device ID | K812759 |
| 510k Number | K812759 |
| Device Name: | NML CK-MB RIA |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-01 |
| Decision Date | 1981-10-19 |