Cleared Traditional

TIPSEP-TBG ASSAY

K861735 · Nuclear Diagnostics, Inc. · Chemistry
Jun 1986
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K861735 is an FDA 510(k) clearance for the TIPSEP-TBG ASSAY, a Radioimmunoassay, Thyroxine-binding Globulin (Class II — Special Controls, product code CEE), submitted by Nuclear Diagnostics, Inc. (Troy, US). The FDA issued a Cleared decision on June 13, 1986, 38 days after receiving the submission on May 6, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1685.

Submission Details

510(k) Number K861735 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1986
Decision Date June 13, 1986
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
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
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