The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Corti-shure.
Device ID | K810033 |
510k Number | K810033 |
Device Name: | CORTI-SHURE |
Classification | Radioimmunoassay, Cortisol |
Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGR |
CFR Regulation Number | 862.1205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-06 |
Decision Date | 1981-01-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CORTI-SHURE 73285232 1236890 Dead/Cancelled |
Nuclear-Medical Laboratories, Inc. 1980-11-10 |