DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A

Enzymatic, Carbon-dioxide

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Carbon Dioxide Enzymatic Assay Kit, Model Kz122a.

Pre-market Notification Details

Device IDK060619
510k NumberK060619
Device Name:DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
ClassificationEnzymatic, Carbon-dioxide
Applicant DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego,  CA  92121
ContactRoland Strickland
CorrespondentRoland Strickland
DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego,  CA  92121
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-08
Decision Date2006-07-21
Summary:summary

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