CI-TROL COAGULATION CONTROLS II & III

Plasma, Coagulation Control

DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Ci-trol Coagulation Controls Ii & Iii.

Pre-market Notification Details

• Device ID: K771346
• 510k Number: K771346
• Device Name: CI-TROL COAGULATION CONTROLS II & III
• Classification: Plasma, Coagulation Control
• Applicant: DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GGN
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1977-07-20
• Decision Date: 1977-08-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768004070	K771346	000
00842768004063	K771346	000
00842768019456	K771346	000
00842768019463	K771346	000