ENZYGNOST F+2 (MONOCLONAL) TEST KIT

Prothrombin Fragment 1.2

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Enzygnost F+2 (monoclonal) Test Kit.

Pre-market Notification Details

• Device ID: K042687
• 510k Number: K042687
• Device Name: ENZYGNOST F+2 (MONOCLONAL) TEST KIT
• Classification: Prothrombin Fragment 1.2
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714
• Contact: Donna Wolf
• Correspondent: Donna Wolf; DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714
• Product Code: MIF
• CFR Regulation Number: 864.7320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-29
• Decision Date: 2004-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768006760	K042687	000