Beta-2-Microglobulin— 510(k) K161297
Substantially EquivalentBeckman Coulter Ireland, Inc.
FDA 510(k) clearance K161297 for Beta-2-Microglobulin, Substantially Equivalent on 2016-06-07. Applicant: Beckman Coulter Ireland, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter Ireland, Inc.
- Product code
- Code JZG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5630
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Co. Clare, IE
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