COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM

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 Venturi Transystem Cary-blair Medium.

Pre-market Notification Details

• Device ID: K946286
• 510k Number: K946286
• Device Name: COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM
• Classification: Culture Media, Non-propagating Transport
• Applicant: COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Contact: Mary M Mcnamara
• Correspondent: Mary M Mcnamara; 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: 1994-12-27
• Decision Date: 1995-03-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
58053326008783	K946286	000
58053326002019	K946286	000
38053326000875	K946286	000