DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL

Urinary Homocystine (nonquantitative) Test System

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, And Calibrators, Model(s) Dzxxxa, Dzxxxa-cal.

Pre-market Notification Details

Device IDK071971
510k NumberK071971
Device Name:DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
ClassificationUrinary Homocystine (nonquantitative) Test System
Applicant DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
ContactCharles Yu
CorrespondentCharles Yu
DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
Product CodeLPS  
CFR Regulation Number862.1377 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-17
Decision Date2007-09-17

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