Cleared Traditional

Elecsys Syphilis

K211302 · Roche Diagnostics · Microbiology
Jul 2021
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K211302 is an FDA 510(k) clearance for the Elecsys Syphilis, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on July 20, 2021, 82 days after receiving the submission on April 29, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K211302 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2021
Decision Date July 20, 2021
Days to Decision 82 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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