Cleared Traditional

COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM

K993161 · Copan Diagnostics, Inc. · Microbiology
Nov 1999
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K993161 is an FDA 510(k) clearance for the COPAN EASY-SWAB 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 November 9, 1999, 48 days after receiving the submission on September 22, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K993161 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1999
Decision Date November 09, 1999
Days to Decision 48 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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