The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Testosterone Diagnostic Kit.
Device ID | K860003 |
510k Number | K860003 |
Device Name: | LEECO TESTOSTERONE DIAGNOSTIC KIT |
Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
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 | CDZ |
CFR Regulation Number | 862.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-02 |
Decision Date | 1986-03-17 |