ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306— 510(k) K994439

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K994439 for ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306, Substantially Equivalent on 2000-01-14. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JHX
Advisory panel: Clinical Chemistry
Date received: 1999-12-23
Decision date: 2000-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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