IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT— 510(k) K060130
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K060130 for IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT, Substantially Equivalent on 2006-02-13. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CZP
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brea, CA, US
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