The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs D-dimer (ddmr) Method (testpak & Dilpak), Models Cddmr & Cddmr-d.
| Device ID | K022976 |
| 510k Number | K022976 |
| Device Name: | STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Contact | Richard M Vaught |
| Correspondent | Richard M Vaught DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 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 | 2002-09-06 |
| Decision Date | 2003-01-16 |
| Summary: | summary |