STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK— 510(k) K063356
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K063356 for STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK, Substantially Equivalent on 2007-03-23. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code DAP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Recalls naming K063356
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063356.
Data sourced from openFDA. This site is unofficial and independent of the FDA.