COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM

Culture Media, Non-propagating Transport

COPAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Copan Diagnostics, Inc. with the FDA for Copan Universal Transport Medium (utm-rt) System.

Pre-market Notification Details

• Device ID: K042970
• 510k Number: K042970
• Device Name: COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
• Classification: Culture Media, Non-propagating Transport
• Applicant: COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Contact: Cynthia Sinclair
• Correspondent: Cynthia Sinclair; COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Product Code: JSM
• CFR Regulation Number: 866.2390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-10-28
• Decision Date: 2004-12-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902205310	K042970	000
30382902202210	K042970	000
30382902202227	K042970	000
30382902202395	K042970	000
30382902202401	K042970	000
30382902202449	K042970	000
30382902205266	K042970	000
30382902205273	K042970	000
30382902205280	K042970	000
30382902205297	K042970	000
30382902202203	K042970	000