The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab T4 Enzyme Immunoassay Kit.
Device ID | K821141 |
510k Number | K821141 |
Device Name: | ENDAB T4 ENZYME IMMUNOASSAY KIT |
Classification | Radioimmunoassay, Total Thyroxine |
Applicant | IMMUNOTECH CORP. 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 | 1982-04-21 |
Decision Date | 1982-05-13 |