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FDA 510(k)

Elecsys Syphilis

K-Number: K211302 · 2021-07-20

ApplicantRoche Diagnostics
Decision Date2021-07-20
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys Syphilis is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2021-07-20 under approval number K211302. 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 Elecsys Syphilis?

Elecsys Syphilis is a medical device that received FDA 510(k) clearance on 2021-07-20. It is manufactured by Roche Diagnostics. The 510(k) number is K211302.

When was Elecsys Syphilis approved by the FDA?

Elecsys Syphilis received FDA 510(k) clearance on 2021-07-20, under approval number K211302.

What company makes Elecsys Syphilis?

Elecsys Syphilis is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys Syphilis?

The FDA product code for Elecsys Syphilis is LIP.

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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 K241427Access SyphilisBeckman Coulter, Inc. K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical 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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