Cleared Traditional

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS

K883085 · Serono Diagnostics, Inc. · Chemistry
Sep 1988
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K883085 is an FDA 510(k) clearance for the T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on September 9, 1988, 49 days after receiving the submission on July 22, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K883085 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1988
Decision Date September 09, 1988
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
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