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FDA 510(k)

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay

K-Number: K163658 · 2017-05-23

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2017-05-23
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K163658. 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 Intact Parathyroid Hormone (PTH) Assay?

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K163658.

When did ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay receive FDA 510(k) clearance?

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay received FDA 510(k) clearance on 2017-05-23, under 510(k) number K163658.

Who is the listed applicant for ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay?

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

What is the FDA product code for ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay?

The FDA product code for ADVIA Centaur Intact Parathyroid Hormone (PTH) 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.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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