INNOVANCE D-DIMER, MODEL OPBP09

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, Model Opbp09.

Pre-market Notification Details

Device IDK093626
510k NumberK093626
Device Name:INNOVANCE D-DIMER, MODEL OPBP09
ClassificationFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark,  DE  19702
ContactKathleen A Dray-lyons
CorrespondentKathleen A Dray-lyons
SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark,  DE  19702
Product CodeDAP  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-24
Decision Date2010-11-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768022821 K093626 000
00842768022814 K093626 000
00630414640501 K093626 000
00630414640488 K093626 000

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