MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A

Test, System, Potassium, Enzymatic Method

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Modification To: Diazyme Potassium Enzymatic Assay, Model Dz113a.

Pre-market Notification Details

Device IDK053566
510k NumberK053566
Device Name:MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
ClassificationTest, System, Potassium, Enzymatic Method
Applicant DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego,  CA  92121
ContactHuan Tran
CorrespondentHuan Tran
DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego,  CA  92121
Product CodeMZV  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-22
Decision Date2006-02-15
Summary:summary

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