The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Immubead T4 Enzyme Immunoassay Kit.
Device ID | K872192 |
510k Number | K872192 |
Device Name: | IMMUBEAD T4 ENZYME IMMUNOASSAY KIT |
Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Contact | E Capitanio |
Correspondent | E Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Product Code | KLI |
CFR Regulation Number | 862.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-08 |
Decision Date | 1987-08-13 |