ADVANCED D-DIMER ASSAY — Dade Behring, Inc. (510(k) K041438)
ADVANCED D-DIMER ASSAY — Dade Behring, Inc. (510(k) K041438) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ADVANCED D-DIMER ASSAY; Applicant: Dade Behring, Inc.; Clearance track: 510(k).
| Device name | ADVANCED D-DIMER ASSAY |
|---|---|
| Applicant | Dade Behring, Inc. |
| Clearance track | 510(k) |
| Submission number | K041438 |
| Decision | Substantially Equivalent |
| Decision date | 2004-08-11 |
| Date received | 2004-06-01 |
| Product code | DAP |
| Device class | 2 |
| Medical specialty | Hematology |
| Applicant location | DE, US |
| Source | openFDA device |
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