ACCESS UNCONJUGATED ESTRIOL CALIBRATORS— 510(k) K012900

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K012900 for ACCESS UNCONJUGATED ESTRIOL CALIBRATORS, Substantially Equivalent on 2001-10-16. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2001-08-29
Decision date: 2001-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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