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FDA 510(k)

Access Total ßhCG (5th IS)

K-Number: K221990 · 2022-12-27

ApplicantBeckman Coulter, Inc.
Decision Date2022-12-27
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Total ßhCG (5th IS) is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-12-27 under 510(k) number K221990. 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 Access Total ßhCG (5th IS)?

Access Total ßhCG (5th IS) is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K221990.

When did Access Total ßhCG (5th IS) receive FDA 510(k) clearance?

Access Total ßhCG (5th IS) received FDA 510(k) clearance on 2022-12-27, under 510(k) number K221990.

Who is the listed applicant for Access Total ßhCG (5th IS)?

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

What is the FDA product code for Access Total ßhCG (5th IS)?

The FDA product code for Access Total ßhCG (5th IS) is DHA.

Other records listing Beckman Coulter, Inc. as applicant

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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 LaboratoriesK212221Diazyme 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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