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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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-05-23 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K163658.

When was ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay approved by the FDA?

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

What company makes ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay?

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay is manufactured by Siemens Healthcare Diagnostics, Inc..

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.

Related PubMed Literature

PMID: 40496061 An improved reporter gene assay for evaluating the biological activity of recombinant human growth hormone. Journal of pharmaceutical analysis (2025)

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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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