ONLINE TDM AMIKA

Amikacin Serum Assay

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Tdm Amika.

Pre-market Notification Details

Device IDK032279
510k NumberK032279
Device Name:ONLINE TDM AMIKA
ClassificationAmikacin Serum Assay
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
ContactKerwin Kaufman
CorrespondentKerwin Kaufman
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeKLP  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-24
Decision Date2003-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336133514 K032279 000

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