The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs D-dimer.
| Device ID | K051597 |
| 510k Number | K051597 |
| Device Name: | STRATUS CS D-DIMER |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 6101 Newark, DE 19714 -6101 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 6101 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 | 2005-06-16 |
| Decision Date | 2005-08-17 |
| Summary: | summary |