DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

HAMILTON CO.

The following data is part of a premarket notification filed by Hamilton Co. with the FDA for Discrete Photometric Chemistry Analyzer.

Pre-market Notification Details

Device IDK943493
510k NumberK943493
Device Name:DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant HAMILTON CO. 3371 LENORA CHURCH OD Snellville,  GA  30278
ContactTimothy Cowart
CorrespondentTimothy Cowart
HAMILTON CO. 3371 LENORA CHURCH OD Snellville,  GA  30278
Product CodeJJE  
Subsequent Product CodeJJQ
Subsequent Product CodeJTC
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-19
Decision Date1995-01-30

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