ACID PHOSPHATASE REAGENT

Acid Phosphatase, Naphthyl Phosphate

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Acid Phosphatase Reagent.

Pre-market Notification Details

Device IDK892393
510k NumberK892393
Device Name:ACID PHOSPHATASE REAGENT
ClassificationAcid Phosphatase, Naphthyl Phosphate
Applicant MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo,  CA  93012
ContactDonna L Anderson
CorrespondentDonna L Anderson
MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo,  CA  93012
Product CodeCKB  
CFR Regulation Number862.1020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-07
Decision Date1989-07-20

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