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510(k) K993107

Device
Bio-rad Homocysteine By Hplc
Applicant
BIO-RAD
510(k) number
K993107
Product code
LPS
Decision
Substantially Equivalent (SESE)
Decision date
1999-12-21
Date received
1999-09-17
Regulation
862.1377
Classification name
Urinary Homocystine (Nonquantitative) Test System
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
Patricia M Klimley
Address
4000 Alfred Nobel Dr. Hercules CA US 94547 94547

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LPS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123930VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.2013-05-15
K121053DIAZYME HOMOCYSTEINE POC TEST KITDiazyme Laboratories2012-07-31
K121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc.2012-06-15
K113793HOMOCYSTEINE TESTRoche2012-06-05
K112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONAxis-Shield Diagnostics, Ltd.2012-05-07
K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Axis-Shield Diagnostics, Ltd.2009-07-31
K080851A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAYAnticancer, Inc.2008-10-10
K073640ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLSAxis-Shield Diagnostics, Ltd.2008-04-24
K071971DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CALDiazyme Laboratories2007-09-17
K063701TECO HOMOCYSTEINE ENZYMATIC ASSAYTeco Diagnostics2007-04-11
K063206DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.2006-12-28
K062808LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENTCatch Incorporated2006-10-13
K061598HEMOSIL HOMOCYSTEINE AND CONTROLSInstrumentation Laboratory CO2006-09-22
K061588VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics, Inc.2006-07-21
K061296DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATORDiazyme Laboratories2006-06-13