DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)— 510(k) K061503
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K061503 for DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A), Substantially Equivalent on 2006-06-22. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code DLJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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