COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM— 510(k) K042970

Name: FDA 510(k) clearance K042970
Creator: U.S. Food and Drug Administration
Published: 2004-12-07

Substantially Equivalent

Copan Diagnostics, Inc.

FDA 510(k) clearance K042970 for COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM, Substantially Equivalent on 2004-12-07. Applicant: Copan Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Copan Diagnostics, Inc.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2004-10-28
Decision date: 2004-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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