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510(k) K926443

Device
Cobas(r)-fp Reagents For T-uptake/calibrators
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K926443
Product code
KHQ
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-20
Date received
1992-12-23
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROL L KRIEGER
Address
1080 Us Hwy. 202 Branchburg NJ US 08876 08876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K933414STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAYBaxter Diagnostics, Inc.1994-11-22
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
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