The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco T3-ria Diagnostic Kit.
Device ID | K830808 |
510k Number | K830808 |
Device Name: | LEECO T3-RIA DIAGNOSTIC KIT |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDP |
CFR Regulation Number | 862.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-14 |
Decision Date | 1983-04-08 |