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FDA 510(k)

ADVIA Centaur® Total hCG assay

K-Number: K200210 · 2021-07-13

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2021-07-13
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur® Total hCG assay is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-07-13 under approval number K200210. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur® Total hCG assay?

ADVIA Centaur® Total hCG assay is a medical device that received FDA 510(k) clearance on 2021-07-13. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200210.

When was ADVIA Centaur® Total hCG assay approved by the FDA?

ADVIA Centaur® Total hCG assay received FDA 510(k) clearance on 2021-07-13, under approval number K200210.

What company makes ADVIA Centaur® Total hCG assay?

ADVIA Centaur® Total hCG assay is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur® Total hCG assay?

The FDA product code for ADVIA Centaur® Total hCG assay is DHA.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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Related Devices (Code: DHA)

K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories K163418Diazyme DZ-Lite Total beta-hCG Test SystemDiazyme Laboratories K192790Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. K192547MAGLUMI 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc. K203227Elecsys HCG STATRoche Diagnostics

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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