COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

Culture Media, Non-propagating Transport

COPAN ITALIA S.P.A.

The following data is part of a premarket notification filed by Copan Italia S.p.a. with the FDA for Copan Fecalswab Collection, Transport And Preservation System.

Pre-market Notification Details

• Device ID: K142094
• 510k Number: K142094
• Device Name: COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
• Classification: Culture Media, Non-propagating Transport
• Applicant: COPAN ITALIA S.P.A. 62 FOREST STREE, SUITE 300 Marlborough, MA 01752
• Contact: Tina Wu
• Correspondent: Tina Wu; COPAN ITALIA S.P.A. 62 FOREST STREE, SUITE 300 Marlborough, MA 01752
• Product Code: JSM
• CFR Regulation Number: 866.2390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-08-01
• Decision Date: 2015-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
58053326002194	K142094	000
38053326000301	K142094	000
38053326000257	K142094	000
38053326002206	K142094	000