The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Lee-bead Beta Fsh (eia).
Device ID | K854837 |
510k Number | K854837 |
Device Name: | LEE-BEAD BETA FSH (EIA) |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
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 | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-03 |
Decision Date | 1986-01-13 |