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FDA 510(k)

Access Syphilis

K-Number: K241427 · 2024-09-06

ApplicantBeckman Coulter, Inc.
Decision Date2024-09-06
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access Syphilis 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 2024-09-06 under 510(k) number K241427. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Syphilis?

Access Syphilis is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K241427.

When did Access Syphilis receive FDA 510(k) clearance?

Access Syphilis received FDA 510(k) clearance on 2024-09-06, under 510(k) number K241427.

Who is the listed applicant for Access Syphilis?

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 Syphilis?

The FDA product code for Access Syphilis is LIP.

Other records listing Beckman Coulter, Inc. as applicant

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.

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Related Devices (Code: LIP)

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.

K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical DiagnosticsK211302Elecsys SyphilisRoche DiagnosticsK170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad LaboratoriesK160910Elecsys SyphilisRoche DiagnosticsK153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc.K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP ControlAbbott Laboratories

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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