The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Dac-cel T3.
Device ID | K791232 |
510k Number | K791232 |
Device Name: | DAC-CEL T3 |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | BURROUGHS WELLCOME CO. 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 | 1979-07-02 |
Decision Date | 1979-09-04 |