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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 a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-12-27 under approval 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. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K221990.

When was Access Total ßhCG (5th IS) approved by the FDA?

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

What company makes Access Total ßhCG (5th IS)?

Access Total ßhCG (5th IS) is manufactured by Beckman Coulter, Inc..

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

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

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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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