Cleared Traditional

Puritan Fecal Opti-Swab Collection and Transport System

K162284 · Puritan Medical Products, LLC · Microbiology
Nov 2016
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K162284 is an FDA 510(k) clearance for the Puritan Fecal Opti-Swab Collection and Transport System, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Puritan Medical Products, LLC (Guilford, US). The FDA issued a Cleared decision on November 4, 2016, 81 days after receiving the submission on August 15, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K162284 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2016
Decision Date November 04, 2016
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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