CLINICAL CHEMISTRY ANALYTICAL SYSTEM

Analyzer, Chemistry, Micro, For Clinical Use

ALLIED INSTRUMENTATION LABORATORY

The following data is part of a premarket notification filed by Allied Instrumentation Laboratory with the FDA for Clinical Chemistry Analytical System.

Pre-market Notification Details

Device IDK851933
510k NumberK851933
Device Name:CLINICAL CHEMISTRY ANALYTICAL SYSTEM
ClassificationAnalyzer, Chemistry, Micro, For Clinical Use
Applicant ALLIED INSTRUMENTATION LABORATORY 113 HARTWELL AVE. Lexington,  MA  02173
ContactGeorge A Lyna
CorrespondentGeorge A Lyna
ALLIED INSTRUMENTATION LABORATORY 113 HARTWELL AVE. Lexington,  MA  02173
Product CodeJJF  
CFR Regulation Number862.2170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-02
Decision Date1985-06-10

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