PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS

Urease And Glutamic Dehydrogenase, Urea Nitrogen

PRECISION SYSTEMS, INC.

The following data is part of a premarket notification filed by Precision Systems, Inc. with the FDA for Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents.

Pre-market Notification Details

Device IDK024182
510k NumberK024182
Device Name:PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant PRECISION SYSTEMS, INC. 16 TECH CIRCLE Natick,  MA  01760
ContactBill Haden
CorrespondentBill Haden
PRECISION SYSTEMS, INC. 16 TECH CIRCLE Natick,  MA  01760
Product CodeCDQ  
Subsequent Product CodeCEO
Subsequent Product CodeCGA
Subsequent Product CodeCGS
Subsequent Product CodeCGX
Subsequent Product CodeCHH
Subsequent Product CodeCHJ
Subsequent Product CodeCIG
Subsequent Product CodeCIT
Subsequent Product CodeCIX
Subsequent Product CodeCJE
Subsequent Product CodeCJY
Subsequent Product CodeJGJ
Subsequent Product CodeJGY
Subsequent Product CodeJJF
Subsequent Product CodeKNK
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-19
Decision Date2003-03-03
Summary:summary

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