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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 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 2021-07-13 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200210.

When did ADVIA Centaur® Total hCG assay receive FDA 510(k) clearance?

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

Who is the listed applicant for ADVIA Centaur® Total hCG 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® Total hCG assay?

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

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Related Devices (Code: DHA)

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.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc.

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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