CHEMISTRY CALIBRATOR

Calibrator, Secondary

JAS Diagnostics, Inc.

The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Chemistry Calibrator.

Pre-market Notification Details

Device IDK020454
510k NumberK020454
Device Name:CHEMISTRY CALIBRATOR
ClassificationCalibrator, Secondary
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 CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-11
Decision Date2002-04-08

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