GELSCAN, MODEL 1206

Electrophoretic, Lactate Dehydrogenase Isoenzymes

SEBIA

The following data is part of a premarket notification filed by Sebia with the FDA for Gelscan, Model 1206.

Pre-market Notification Details

Device IDK100307
510k NumberK100307
Device Name:GELSCAN, MODEL 1206
ClassificationElectrophoretic, Lactate Dehydrogenase Isoenzymes
Applicant SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross,  GA  30093
ContactKaren Anderson
CorrespondentKaren Anderson
SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross,  GA  30093
Product CodeCFE  
Subsequent Product CodeCIN
Subsequent Product CodeJHY
Subsequent Product CodeJQT
CFR Regulation Number862.1445 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-03
Decision Date2010-08-31

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