Access AMH— 510(k) K170524

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K170524 for Access AMH, Substantially Equivalent on 2017-11-13. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code PQO
Advisory panel: Clinical Chemistry
Date received: 2017-02-22
Decision date: 2017-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.