The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme T3 Enzyme Immunoassay Kit.
Device ID | K904820 |
510k Number | K904820 |
Device Name: | MICROZYME T3 ENZYME IMMUNOASSAY KIT |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Contact | Francis E Capitanio |
Correspondent | Francis E Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Product Code | CDP |
CFR Regulation Number | 862.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-24 |
Decision Date | 1990-12-18 |