ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY— 510(k) K023597

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K023597 for ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 2002-12-11. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LTK
Advisory panel: Immunology
Date received: 2002-10-28
Decision date: 2002-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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