The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Nml 6000 Ct.
Device ID | K823679 |
510k Number | K823679 |
Device Name: | NML 6000 CT |
Classification | Calculator/data Processing Module, For Clinical Use |
Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQP |
CFR Regulation Number | 862.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-07 |
Decision Date | 1983-01-07 |