ACCESS OV MONITOR ASSAY— 510(k) K031297

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K031297 for ACCESS OV MONITOR ASSAY, Substantially Equivalent on 2003-05-02. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LTK
Advisory panel: Immunology
Date received: 2003-04-24
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

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