INNOVANCE Free PS Ag

Test, Qualitative And Quantitative Factor Deficiency

Siemens Healthcare Diagnostics Products GmbH

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Gmbh with the FDA for Innovance Free Ps Ag.

Pre-market Notification Details

Device IDK181525
510k NumberK181525
Device Name:INNOVANCE Free PS Ag
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Strasse 76 Marburg,  DE 35041
ContactPetra Dissmann
CorrespondentPetra Dissmann
Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Strasse 76 Marburg,  DE 35041
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-11
Decision Date2018-09-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768039522 K181525 000
00630414639826 K181525 000

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