Cleared Traditional

Puritan OptiTranz Liquid Stuart Collection and Transport System

K142366 · Puritan Medical Products, LLC · Microbiology
Jan 2015
Decision
137d
Days
Class 1
Risk

About This 510(k) Submission

K142366 is an FDA 510(k) clearance for the Puritan OptiTranz Liquid Stuart 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 January 9, 2015, 137 days after receiving the submission on August 25, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K142366 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2014
Decision Date January 09, 2015
Days to Decision 137 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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