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510(k) K801012

Device
TRIGLYCERIDE REAGENT (COLOR)
Applicant
GILFORD DIAGNOSTICS
510(k) number
K801012
Product code
JGY  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-14
Date received
1980-04-28
Regulation
862.1705
Classification name
Colorimetric Method, Triglycerides
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JGY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMAbaxis, Inc.2012-04-24
K023639PICCOLO TRIGLYCERIDES TEST SYSTEMAbaxis, Inc.2003-01-24
K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.2000-07-03
K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.2000-05-24
K971005TRIGLYCERIDESDerma Media Lab., Inc.1997-04-21
K954187TRIGLYCERIDES REAGENTSchiapparelli Biosystems, Inc.1995-10-23
K941063DNA TRIGLYCERIDE PROCEDUREData Medical Associates, Inc.1994-07-20
K931116IL TEST(TM) TRIGLYCERIDEInstrumentation Laboratory CO1994-03-28
K914033CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TESTCholestech Corp.1991-09-27
K905226TRIGLYCERIDE (GPO) REAGENT, UNIVERSALEnzyme Technology, Inc.1990-12-11
K902202DMA TRIGLYCERIDE (GPO) PROCEDUREData Medical Associates, Inc.1990-07-31
K894063TRIGLYCERIDE (GPO) TRINDER REAGENTSigma Diagnostics, Inc.1989-09-07
K885134CLINISTAT TRIGLYCERIDES REAGENT TESTHeraeus Kulzer, Inc.1989-02-10
K860731TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)Trace Scientific , Ltd.1986-04-07
K832460TRIGLYCERIDE REAGENT-TRINDER-GPOSeppim, Inc.1983-09-12

Legacy Summary#

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FDA Review#

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