COBAS INTEGRA AMIKACIN MAB

Fluorescence Polarization Immunoassay, Amibacin

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Amikacin Mab.

Pre-market Notification Details

Device IDK991597
510k NumberK991597
Device Name:COBAS INTEGRA AMIKACIN MAB
ClassificationFluorescence Polarization Immunoassay, Amibacin
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis,  IN  46250 -0457
ContactLisa Gerard
CorrespondentLisa Gerard
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis,  IN  46250 -0457
Product CodeLGJ  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-10
Decision Date1999-07-22
Summary:summary

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