ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER— 510(k) K000716
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K000716 for ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, Substantially Equivalent on 2000-03-20. Applicant: Beckman Coulter, Inc..
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code JHX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chaska, MN, US
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