JAS CALCIUM (ARSENAZO) REAGENT

Azo Dye, Calcium

JAS Diagnostics, Inc.

The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Jas Calcium (arsenazo) Reagent.

Pre-market Notification Details

Device IDK011441
510k NumberK011441
Device Name:JAS CALCIUM (ARSENAZO) REAGENT
ClassificationAzo Dye, Calcium
Applicant JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami,  FL  33166
ContactDavid Johnston
CorrespondentDavid Johnston
JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami,  FL  33166
Product CodeCJY  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-10
Decision Date2001-07-09

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