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FDA 510(k)

VITROS Immunodiagnostic Products Syphilis Reagent Pack

K-Number: K241534 · 2024-08-28

ApplicantOrtho Clinical Diagnostics
Decision Date2024-08-28
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITROS Immunodiagnostic Products Syphilis Reagent Pack is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2024-08-28 under 510(k) number K241534. 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 VITROS Immunodiagnostic Products Syphilis Reagent Pack?

VITROS Immunodiagnostic Products Syphilis Reagent Pack is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K241534.

When did VITROS Immunodiagnostic Products Syphilis Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products Syphilis Reagent Pack received FDA 510(k) clearance on 2024-08-28, under 510(k) number K241534.

Who is the listed applicant for VITROS Immunodiagnostic Products Syphilis Reagent Pack?

The FDA 510(k) record lists Ortho Clinical Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS Immunodiagnostic Products Syphilis Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products Syphilis Reagent Pack is LIP.

Other records listing Ortho Clinical Diagnostics 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.

K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackK233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackK221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackK231517VITROS Immunodiagnostic Products CEA Reagent PackK231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackPMA P100001Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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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.

K241427Access SyphilisBeckman Coulter, Inc.K211302Elecsys 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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