DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET

C-reactive Protein, Antigen, Antiserum, And Control

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Hs Crp Assay Kit / Calibrator Set / Control Set.

Pre-market Notification Details

Device IDK103557
510k NumberK103557
Device Name:DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
ContactAbhijit Datta
CorrespondentAbhijit Datta
DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
Product CodeDCK  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-02
Decision Date2011-04-27
Summary:summary

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