DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B

Atomic Absorption, Lithium

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Liquid Stable Enzymatic Lithium Assay, Model Dz116b.

Pre-market Notification Details

Device IDK082001
510k NumberK082001
Device Name:DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
ClassificationAtomic Absorption, Lithium
Applicant DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
ContactAbhijit Datta
CorrespondentAbhijit Datta
DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
Product CodeJII  
CFR Regulation Number862.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-14
Decision Date2008-12-05

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