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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 a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2024-08-28 under approval 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. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K241534.

When was VITROS Immunodiagnostic Products Syphilis Reagent Pack approved by the FDA?

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

What company makes VITROS Immunodiagnostic Products Syphilis Reagent Pack?

VITROS Immunodiagnostic Products Syphilis Reagent Pack is manufactured by Ortho Clinical Diagnostics.

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 Devices by Ortho Clinical Diagnostics

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Related Devices (Code: LIP)

K160910Elecsys SyphilisRoche Diagnostics K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc. K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP ControlAbbott Laboratories K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories K211302Elecsys SyphilisRoche Diagnostics K241427Access SyphilisBeckman Coulter, Inc.

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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