The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Spac T3 Ria Test Kit.
Device ID | K801125 |
510k Number | K801125 |
Device Name: | SPAC T3 RIA TEST KIT |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | MALLINCKRODT CRITICAL CARE 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 | 1980-05-12 |
Decision Date | 1980-06-09 |