Cleared Traditional

TRANSPORT CULTURE MEDIUM DEVICE

K120846 · Puritan Medical Products, LLC · Microbiology
Jun 2012
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K120846 is an FDA 510(k) clearance for the TRANSPORT CULTURE MEDIUM DEVICE, 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 June 8, 2012, 80 days after receiving the submission on March 20, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K120846 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2012
Decision Date June 08, 2012
Days to Decision 80 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

Similar Devices — LIO Device, Specimen Collection

All 62
ARX Liquid Amies Collection & Transport System
K222613 · Arx Sciences, Inc. · Mar 2024
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
K131630 · Puritan Medical Products, LLC · Oct 2013
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
K103805 · Medical Wire & Equipment Company (Bath), Ltd. · Jan 2011
VIROCULT, MODEL MW950
K082472 · Medical Wire & Equipment Company (Bath), Ltd. · Dec 2008
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
K070062 · Diesse Diagnostica Senese S.P.A. · Jul 2007
BACTI-SWAB DRY
K013711 · Remel Co. · Nov 2001