INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Innovance D-dimer And Innovance D-dimer Controls.

Pre-market Notification Details

Device IDK081732
510k NumberK081732
Device Name:INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
ClassificationFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark,  DE  19702
ContactKathleen A Dray-lyons
CorrespondentKathleen A Dray-lyons
SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark,  DE  19702
Product CodeDAP  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-19
Decision Date2008-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768027611 K081732 000
00842768023668 K081732 000
00630414640181 K081732 000
00842768019265 K081732 000

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