FDA.reportPublic FDA data

510(k) K931116

Device
Il Test(tm) Triglyceride
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K931116
Product code
JGY
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-28
Date received
1993-03-04
Regulation
862.1705
Classification name
Colorimetric Method, Triglycerides
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WALLIS W CADY
Address
113 Hartwell Ave. P.O. Box 9113 Lexington MA US 02173 02173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K821106TRIGLYZYME V EIKENSyn-Kit, Inc.1982-05-05