ACTIVATOR

Activated Whole Blood Clotting Time

TRI-MED, INC.

The following data is part of a premarket notification filed by Tri-med, Inc. with the FDA for Activator.

Pre-market Notification Details

• Device ID: K790346
• 510k Number: K790346
• Device Name: ACTIVATOR
• Classification: Activated Whole Blood Clotting Time
• Applicant: TRI-MED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JBP
• CFR Regulation Number: 864.7140 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-02-21
• Decision Date: 1979-03-21