Cleared Traditional

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set

K170413 · Bio-Rad Laboratories · Microbiology
May 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K170413 is an FDA 510(k) clearance for the BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on May 11, 2017, 90 days after receiving the submission on February 10, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K170413 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2017
Decision Date May 11, 2017
Days to Decision 90 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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