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 |