The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Concep-7-b-hcg.
Device ID | K790397 |
510k Number | K790397 |
Device Name: | CONCEP-7-B-HCG |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | LEECO DIAGNOSTICS, 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 | 1979-02-26 |
Decision Date | 1979-05-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CONCEP-7-B-HCG 73756109 1562969 Dead/Cancelled |
LEECO DIAGNOSTICS, INC. 1988-10-05 |