STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs Acute Care D-dimer Testpak, Dilpak, Calpak.

Pre-market Notification Details

• Device ID: K063356
• 510k Number: K063356
• Device Name: STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
• Classification: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101
• Contact: Pamela A Jurga
• Correspondent: Pamela A Jurga; DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101
• Product Code: DAP
• CFR Regulation Number: 864.7320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-07
• Decision Date: 2007-03-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768004582	K063356	000
00842768004575	K063356	000