ACCESS TOTAL T4 ASSAY— 510(k) K023369

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K023369 for ACCESS TOTAL T4 ASSAY, Substantially Equivalent on 2002-12-09. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code KLI
Advisory panel: Clinical Chemistry
Date received: 2002-10-08
Decision date: 2002-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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