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510(k) K933414

Device
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY
Applicant
BAXTER DIAGNOSTICS, INC.
510(k) number
K933414
Product code
KHQ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-22
Date received
1993-07-13
Regulation
862.1715
Classification name
Radioassay, Triiodothyronine Uptake
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RONALD H LENTSCH
Address
P.O.Box 520672 Miami FL US 33152 33152

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KHQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.1998-06-10
K980088T-UPTAKE MICROPLATE EIAMonobind1998-02-04
K970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.1997-03-24
K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.1996-06-12
K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.1995-12-21
K951586T-UPTAKE EIA TESTDiagnostic Reagents, Inc.1995-05-15
K934312AXSYM(TM) T-UPTAKEAbbott Laboratories1994-06-21
K935816VIDAS T UPTAKEBiomerieux Vitek, Inc.1994-03-22
K926220T3 UPTAKE CHEMILUMINESCENCE ASSAYNichols Institute Diagnostics1993-11-17
K931294IQ TUPTAKE ASSAYBecton Dickinson Advanced Diagnostics1993-07-22
K926443COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORSRoche Diagnostic Systems, Inc.1993-05-20
K925257CIBA CORNING ACS T UPTAKE IMMUNOASSAYCiba Corning Diagnostics Corp.1992-12-28
K923676VISTA THYROXINE UPTAKE ASSAYSyva Co.1992-10-09
K913663AIA-PACK T-UTosoh Corp.1991-09-30

Legacy Summary#

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FDA Review#

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