The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Testo-quant Diag. Kit.
Device ID | K813059 |
510k Number | K813059 |
Device Name: | LEECO TESTO-QUANT DIAG. KIT |
Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
Applicant | LEECO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CDZ |
CFR Regulation Number | 862.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-30 |
Decision Date | 1981-11-16 |