Cleared Traditional

Elecsys Syphilis

K160910 · Roche Diagnostics · Microbiology
Jul 2016
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K160910 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 28, 2016, 118 days after receiving the submission on April 1, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K160910 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2016
Decision Date July 28, 2016
Days to Decision 118 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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