Cleared Traditional

COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM

K061301 · Copan Diagnostics, Inc. · Microbiology
Jun 2006
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K061301 is an FDA 510(k) clearance for the COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM, a System, Transport, Aerobic (Class I — General Controls, product code JTW), submitted by Copan Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on June 23, 2006, 44 days after receiving the submission on May 10, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K061301 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2006
Decision Date June 23, 2006
Days to Decision 44 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTW — System, Transport, Aerobic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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