MULTIGENT GENTAMICIN

Enzyme Immunoassay, Gentamicin

SERADYN INC.

The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Multigent Gentamicin.

Pre-market Notification Details

Device IDK060709
510k NumberK060709
Device Name:MULTIGENT GENTAMICIN
ClassificationEnzyme Immunoassay, Gentamicin
Applicant SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
ContactEarl E Knight
CorrespondentEarl E Knight
SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
Product CodeLCD  
CFR Regulation Number862.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-16
Decision Date2006-06-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740135522 K060709 000
00380740000301 K060709 000

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