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FDA 510(k)

Access BR Monitor

K-Number: K240403 · 2024-05-09

ApplicantBeckman Coulter, Inc.
Decision Date2024-05-09
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Access BR Monitor 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 2024-05-09 under 510(k) number K240403. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access BR Monitor?

Access BR Monitor is a medical device that received FDA 510(k) clearance on 2024-05-09. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K240403.

When did Access BR Monitor receive FDA 510(k) clearance?

Access BR Monitor received FDA 510(k) clearance on 2024-05-09, under 510(k) number K240403.

Who is the listed applicant for Access BR Monitor?

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 BR Monitor?

The FDA product code for Access BR Monitor is MOI.

Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: MOI)

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.

K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche DiagnosticsK171605Elecsys CA 15-3 IIRoche 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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