The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Immubead Thyroid Uptake.
Device ID | K872172 |
510k Number | K872172 |
Device Name: | IMMUBEAD THYROID UPTAKE |
Classification | Radioassay, Triiodothyronine Uptake |
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 | KHQ |
CFR Regulation Number | 862.1715 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-08 |
Decision Date | 1987-08-17 |