Cleared Special

MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE

K103805 · Medical Wire & Equipment Company (Bath), Ltd. · Microbiology

Jan 2011

Decision

28d

Days

Class 1

Risk

About This 510(k) Submission

K103805 is an FDA 510(k) clearance for the MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Medical Wire & Equipment Company (Bath), Ltd. (Corsham, Wiltshire, GB). The FDA issued a Cleared decision on January 25, 2011, 28 days after receiving the submission on December 28, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number	K103805 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2010
Decision Date	January 25, 2011
Days to Decision	28 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF