Cleared Traditional

COPAN VIRAL TRANSYSTEM

K001780 · Copan Diagnostics, Inc. · Microbiology
Jul 2001
Decision
413d
Days
Class 1
Risk

About This 510(k) Submission

K001780 is an FDA 510(k) clearance for the COPAN VIRAL TRANSYSTEM, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Copan Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 31, 2001, 413 days after receiving the submission on June 13, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K001780 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2000
Decision Date July 31, 2001
Days to Decision 413 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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