MINICAP IMMUNOTYPING, MODEL: 2300

Immunoelectrophoretic, Immunoglobulins, (g, A, M)

SEBIA

The following data is part of a premarket notification filed by Sebia with the FDA for Minicap Immunotyping, Model: 2300.

Pre-market Notification Details

Device IDK082388
510k NumberK082388
Device Name:MINICAP IMMUNOTYPING, MODEL: 2300
ClassificationImmunoelectrophoretic, Immunoglobulins, (g, A, M)
Applicant SEBIA 400-1705 CORPORATE DRIVE Norcross,  GA  30093
ContactKaren Anderson
CorrespondentKaren Anderson
SEBIA 400-1705 CORPORATE DRIVE Norcross,  GA  30093
Product CodeCFF  
Subsequent Product CodeCEF
Subsequent Product CodeDEH
Subsequent Product CodeDFH
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-19
Decision Date2009-04-14

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