Cleared Traditional

T3 UPTAKE TEST

K780361 · Monobind · Immunology
Mar 1978
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K780361 is an FDA 510(k) clearance for the T3 UPTAKE TEST, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on March 22, 1978, 16 days after receiving the submission on March 6, 1978. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K780361 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1978
Decision Date March 22, 1978
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code KHQ — Radioassay, Triiodothyronine Uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1715

Similar Devices — KHQ Radioassay, Triiodothyronine Uptake

All 92
ACE T UPTAKE REAGENT TU CALIBRATORS
K981375 · Schiapparelli Biosystems, Inc. · Jun 1998
T-UPTAKE MICROPLATE EIA
K980088 · Monobind · Feb 1998
CHIRON DIAGNOSTICS ACS:180TU P
K970539 · Chiron Diagnostics Corp. · Mar 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
K964308 · Johnson & Johnson Clinical Diagnostics, Inc. · Nov 1996
ELECSYS T-UPTAKE ASSAY
K961488 · Boehringer Mannheim Corp. · Jun 1996
CEDIA T UPTAKE ASSAY
K954807 · Boehringer Mannheim Corp. · Dec 1995