ATAC PAK ALP REAGENT KIT

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

ELAN DIAGNOSTICS

The following data is part of a premarket notification filed by Elan Diagnostics with the FDA for Atac Pak Alp Reagent Kit.

Pre-market Notification Details

Device IDK002285
510k NumberK002285
Device Name:ATAC PAK ALP REAGENT KIT
ClassificationNitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant ELAN DIAGNOSTICS 231 NORTH PUENTE ST. Brea,  CA  92821
ContactWynn Stocking
CorrespondentWynn Stocking
ELAN DIAGNOSTICS 231 NORTH PUENTE ST. Brea,  CA  92821
Product CodeCJE  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-26
Decision Date2000-09-26

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