The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco E2 Quant Diag. Test Kit.
Device ID | K834586 |
510k Number | K834586 |
Device Name: | LEECO E2 QUANT DIAG. TEST KIT |
Classification | Radioimmunoassay, Estradiol |
Applicant | LEECO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CHP |
CFR Regulation Number | 862.1260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-29 |
Decision Date | 1984-03-09 |