CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS

System, Multipurpose For In Vitro Coagulation Studies

HEMOTEC, INC.

The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Clotrac Citrated Whole Blood Coagulation Controls.

Pre-market Notification Details

• Device ID: K894359
• 510k Number: K894359
• Device Name: CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS
• Classification: System, Multipurpose For In Vitro Coagulation Studies
• Applicant: HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112
• Contact: Baugh, Phd
• Correspondent: Baugh, Phd; HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112
• Product Code: JPA
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-07-14
• Decision Date: 1989-09-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00673978519173	K894359	000
20763000014876	K894359	000
20763000014814	K894359	000
20613994130383	K894359	000