Access Myoglobin— 510(k) K231832
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K231832 for Access Myoglobin, Substantially Equivalent on 2023-09-18. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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More clearances from Beckman Coulter, Inc.
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