Cleared Traditional

ACCESS THYROID UPTAKE ASSAY

K930010 · Bio-Rad Laboratories, Inc. · Chemistry
Jun 1993
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K930010 is an FDA 510(k) clearance for the ACCESS THYROID UPTAKE ASSAY, a Radioimmunoassay, Thyroxine-binding Globulin (Class II — Special Controls, product code CEE), submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on June 7, 1993, 154 days after receiving the submission on January 4, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1685.

Submission Details

510(k) Number K930010 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1993
Decision Date June 07, 1993
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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
IMMULITE(TM) T-UPTAKE
K910677 · Cirrus Diagnostics, Inc. · Apr 1991
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
K905777 · Immunotech Corp. · Jan 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