The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for T3 Uptake Kits.
Device ID | K822612 |
510k Number | K822612 |
Device Name: | T3 UPTAKE KITS |
Classification | Radioassay, Triiodothyronine Uptake |
Applicant | PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KHQ |
CFR Regulation Number | 862.1715 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-30 |
Decision Date | 1982-09-30 |