The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Lacti-quant.
Device ID | K801849 |
510k Number | K801849 |
Device Name: | LACTI-QUANT |
Classification | Radioimmunoassay, Prolactin (lactogen) |
Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFT |
CFR Regulation Number | 862.1625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-04 |
Decision Date | 1980-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LACTI-QUANT 73289021 1225631 Dead/Cancelled |
Nuclear-Medical Laboratories, Inc. 1980-12-08 |