The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Fsh-quant Diagnostic Kit.
Device ID | K810663 |
510k Number | K810663 |
Device Name: | LEECO FSH-QUANT DIAGNOSTIC KIT |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
Applicant | LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-11 |
Decision Date | 1981-03-27 |