The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Concep-7-bhcg.
Device ID | K792308 |
510k Number | K792308 |
Device Name: | CONCEP-7-BHCG |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | LEECO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-16 |
Decision Date | 1979-12-06 |