DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114— 510(k) K033525
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K033525 for DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114, Substantially Equivalent on 2004-01-12. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code DCF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5040
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- P.O. Box 6101, Newark, DE, US
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