Cleared Traditional

MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT

K905777 · Immunotech Corp. · Immunology
Jan 1991
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K905777 is an FDA 510(k) clearance for the MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT, a Radioimmunoassay, Thyroxine-binding Globulin (Class II — Special Controls, product code CEE), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on January 30, 1991, 34 days after receiving the submission on December 27, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1685.

Submission Details

510(k) Number K905777 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1990
Decision Date January 30, 1991
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CEE — Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1685

Similar Devices — CEE Radioimmunoassay, Thyroxine-binding Globulin

All 24
AMERLITE TBG ASSAY
K952284 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
ACCESS THYROID UPTAKE ASSAY
K930010 · Bio-Rad Laboratories, Inc. · Jun 1993
IMMULITE(TM) T-UPTAKE
K910677 · Cirrus Diagnostics, Inc. · Apr 1991
DELFIA TBG KIT
K900240 · Pharmacia, Inc. · Mar 1990
ENZYMUN TEST(R) TBK
K896991 · Boehringer Mannheim Corp. · Mar 1990
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469 · Amersham Corp. · Aug 1989