DIAZYME CYSTATIN C ASSAY

Test, Cystatin C

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Cystatin C Assay.

Pre-market Notification Details

Device IDK093680
510k NumberK093680
Device Name:DIAZYME CYSTATIN C ASSAY
ClassificationTest, Cystatin C
Applicant DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
ContactAbhijit Datta
CorrespondentAbhijit Datta
DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
Product CodeNDY  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-27
Decision Date2010-04-08

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