DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent— 510(k) K162208
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K162208 for DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent, Substantially Equivalent on 2017-01-09. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CFN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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