The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme Thyroid Uptake Enzyme Immunoassay Kit.
Device ID | K905777 |
510k Number | K905777 |
Device Name: | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT |
Classification | Radioimmunoassay, Thyroxine-binding Globulin |
Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Contact | Francis Capitanio |
Correspondent | Francis Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Product Code | CEE |
CFR Regulation Number | 862.1685 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-27 |
Decision Date | 1991-01-30 |