COATEST HEPARIN

Assay, Heparin

KABIVITRUM, INC.

The following data is part of a premarket notification filed by Kabivitrum, Inc. with the FDA for Coatest Heparin.

Pre-market Notification Details

• Device ID: K833891
• 510k Number: K833891
• Device Name: COATEST HEPARIN
• Classification: Assay, Heparin
• Applicant: KABIVITRUM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KFF
• CFR Regulation Number: 864.7525 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-11-09
• Decision Date: 1984-01-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08426950088196	K833891	000