AMYLASE SR LIQUID STABLE REAGENT SET

Catalytic Methods, Amylase

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Amylase Sr Liquid Stable Reagent Set.

Pre-market Notification Details

Device IDK885176
510k NumberK885176
Device Name:AMYLASE SR LIQUID STABLE REAGENT SET
ClassificationCatalytic Methods, Amylase
Applicant MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo,  CA  93012
ContactL Anderson
CorrespondentL Anderson
MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo,  CA  93012
Product CodeJFJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-14
Decision Date1989-02-17

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