BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203— 510(k) K092505
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K092505 for BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203, Substantially Equivalent on 2009-12-11. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Co. Clare, IE
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