ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)

Single (specified) Analyte Controls (assayed And Unassayed)

SIEMENS HEALTHCARE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur C-peptide (cps) Master Curve Material (mcm), Advia Centaur Insulin (iri) Master Curve Material (mcm).

Pre-market Notification Details

Device IDK142864
510k NumberK142864
Device Name:ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown,  NY  10591
ContactFatima Pacheco
CorrespondentFatima Pacheco
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown,  NY  10591
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-01
Decision Date2014-10-29
Summary:summary

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