Cleared Traditional

T-UPTAKE MICROPLATE EIA

K980088 · Monobind · Chemistry
Feb 1998
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K980088 is an FDA 510(k) clearance for the T-UPTAKE MICROPLATE EIA, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on February 4, 1998, 26 days after receiving the submission on January 9, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K980088 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1998
Decision Date February 04, 1998
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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
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
T-UPTAKE EIA TEST
K951586 · Diagnostic Reagents, Inc. · May 1995