DIAZYME SODIUM ENZYMATIC ASSAY

System, Test, Sodium, Enzymatic Method

DIAZYME LABORATORIES

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

Pre-market Notification Details

Device IDK042189
510k NumberK042189
Device Name:DIAZYME SODIUM ENZYMATIC ASSAY
ClassificationSystem, Test, Sodium, Enzymatic Method
Applicant DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego,  CA  92121
ContactHuhan Tran
CorrespondentHuhan Tran
DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego,  CA  92121
Product CodeMZU  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-12
Decision Date2004-10-07
Summary:summary

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