The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Chorio-quant.
Device ID | K820523 |
510k Number | K820523 |
Device Name: | CHORIO-QUANT |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-26 |
Decision Date | 1982-03-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CHORIO-QUANT 73257750 1212870 Dead/Cancelled |
Nuclear-Medical Laboratories, Inc. 1980-04-11 |