The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Testo-quant Diagnostic Kit.
Device ID | K803001 |
510k Number | K803001 |
Device Name: | LEECO TESTO-QUANT DIAGNOSTIC KIT |
Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
Applicant | LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDZ |
CFR Regulation Number | 862.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-25 |
Decision Date | 1981-01-02 |