The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco T4 Quant Diagnostics Test Kit.
Device ID | K822399 |
510k Number | K822399 |
Device Name: | LEECO T4 QUANT DIAGNOSTICS TEST KIT |
Classification | Radioimmunoassay, Total Thyroxine |
Applicant | LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDX |
CFR Regulation Number | 862.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-10 |
Decision Date | 1982-09-13 |