Cleared Traditional

COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM

K946288 · Copan Diagnostics, Inc. · Microbiology
Mar 1995
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K946288 is an FDA 510(k) clearance for the COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM, 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 March 10, 1995, 73 days after receiving the submission on December 27, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K946288 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1994
Decision Date March 10, 1995
Days to Decision 73 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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