K000716

Substantially Equivalent

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER

Applicant: Beckman Coulter, Inc.
Product code: JHX
Advisory panel: Clinical Chemistry
Date received: 2000-03-03
Decision date: 2000-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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