ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY

Radioimmunoassay, Parathyroid Hormone

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Centaur Inact Parathyroid Hormone (ipth) Assay.

Pre-market Notification Details

Device IDK121981
510k NumberK121981
Device Name:ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown,  NY  10591
ContactPhilip Liu
CorrespondentPhilip Liu
SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-06
Decision Date2013-03-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414585352 K121981 000
00630414585345 K121981 000

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