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KHQ — Radioassay, Triiodothyronine Uptake Class II

FDA Device Classification

Classification Details

Product Code
KHQ
Device Class
Class II
Regulation Number
862.1715
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K981375schiapparelli biosystemsACE T UPTAKE REAGENT TU CALIBRATORSJune 10, 1998
K980088monobindT-UPTAKE MICROPLATE EIAFebruary 4, 1998
K970539chiron diagnosticsCHIRON DIAGNOSTICS ACS:180TU PMarch 24, 1997
K964308johnson and johnson clinical diagnosticsVITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKNovember 27, 1996
K961488boehringer mannheimELECSYS T-UPTAKE ASSAYJune 12, 1996
K954807boehringer mannheimCEDIA T UPTAKE ASSAYDecember 21, 1995
K951586diagnostic reagentsT-UPTAKE EIA TESTMay 15, 1995
K933414baxter diagnosticsSTRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAYNovember 22, 1994
K934312abbott laboratoriesAXSYM(TM) T-UPTAKEJune 21, 1994
K935816biomerieux vitekVIDAS T UPTAKEMarch 22, 1994
K926220nichols institute diagnosticsT3 UPTAKE CHEMILUMINESCENCE ASSAYNovember 17, 1993
K931294becton dickinson advanced diagnosticsIQ TUPTAKE ASSAYJuly 22, 1993
K926443roche diagnostic systemsCOBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORSMay 20, 1993
K925257ciba corning diagnosticsCIBA CORNING ACS T UPTAKE IMMUNOASSAYDecember 28, 1992
K923676syvaVISTA THYROXINE UPTAKE ASSAYOctober 9, 1992
K913663tosohAIA-PACK T-USeptember 30, 1991
K911912serono-baker diagnosticsSR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)September 18, 1991
K911093ciba corning diagnosticsCIBA CORNING ACS T UPTAKE IMMUNOASSAYApril 29, 1991
K903396instrumentation laboratoryIL T UPTAKE ASSAY SYSTEMOctober 12, 1990
K902748advanced magneticsSEROZYME FREE T3 IMMUNOASSAYAugust 9, 1990