The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Nml 5000 Auto. Gamma Scint. Counter.
| Device ID | K800388 |
| 510k Number | K800388 |
| Device Name: | NML 5000 AUTO. GAMMA SCINT. COUNTER |
| Classification | Counter (beta, Gamma) For Clinical Use |
| Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-25 |
| Decision Date | 1980-03-12 |