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FDA 510(k)

ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY

K-Number: K121981 · 2013-03-21

ApplicantSiemens Healthcare Diagnostics
Decision Date2013-03-21
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2013-03-21 under 510(k) number K121981. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY?

ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY is a medical device that received FDA 510(k) clearance on 2013-03-21. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K121981.

When did ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY receive FDA 510(k) clearance?

ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY received FDA 510(k) clearance on 2013-03-21, under 510(k) number K121981.

Who is the listed applicant for ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY?

The FDA product code for ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY is CEW.

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Related Devices (Code: CEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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