ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL

Single (specified) Analyte Controls (assayed And Unassayed)

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Centaur Cyclosporine Master Curve Material.

Pre-market Notification Details

Device IDK092993
510k NumberK092993
Device Name:ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown,  NY  10591
ContactClare Santulli
CorrespondentClare Santulli
SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-28
Decision Date2009-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414598758 K092993 000
00630414523798 K092993 000

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