Cleared Traditional

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM

K131630 · Puritan Medical Products, LLC · Microbiology
Oct 2013
Decision
139d
Days
Class 1
Risk

About This 510(k) Submission

K131630 is an FDA 510(k) clearance for the PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Puritan Medical Products, LLC (Guilford, US). The FDA issued a Cleared decision on October 21, 2013, 139 days after receiving the submission on June 4, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K131630 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2013
Decision Date October 21, 2013
Days to Decision 139 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIO — Device, Specimen Collection
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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