ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY— 510(k) K023597

Name: FDA 510(k) clearance K023597
Creator: U.S. Food and Drug Administration
Published: 2002-12-11

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.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2002-10-28
Decision date: 2002-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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