FDA 510(k)

Elecsys Syphilis

K-Number: K211302 · 2021-07-20

Decision Date2021-07-20

Product CodeLIP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Elecsys Syphilis is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2021-07-20 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K211302.

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

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

Who is the listed applicant for Elecsys Syphilis?

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

What is the FDA product code for Elecsys Syphilis?

The FDA product code for Elecsys Syphilis is LIP.

Other records listing Roche 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.

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Related Devices (Code: LIP)

K241427Access SyphilisBeckman Coulter, Inc.K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories 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

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.