HEMOCHRON SIGNATURE ELITE

System, Multipurpose For In Vitro Coagulation Studies

INTERNATIONAL TECHNIDYNE CORP.

The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Signature Elite.

Pre-market Notification Details

• Device ID: K050016
• 510k Number: K050016
• Device Name: HEMOCHRON SIGNATURE ELITE
• Classification: System, Multipurpose For In Vitro Coagulation Studies
• Applicant: INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820
• Contact: Leslie Young
• Correspondent: Leslie Young; INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820
• Product Code: JPA
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-01-04
• Decision Date: 2005-02-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10711234540039	K050016	000