The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Concep-7-bhcg (eia).
Device ID | K844153 |
510k Number | K844153 |
Device Name: | CONCEP-7-BHCG (EIA) |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
Contact | James P Lee |
Correspondent | James P Lee LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-24 |
Decision Date | 1984-12-14 |