The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Chorio-shure.
Device ID | K810936 |
510k Number | K810936 |
Device Name: | CHORIO-SHURE |
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 | 1981-04-07 |
Decision Date | 1981-04-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CHORIO-SHURE 73230558 1156024 Dead/Cancelled |
NUCLEAR-MEDICAL LABORATORIES, INC. 1979-09-07 |