K191514

Substantially Equivalent

CareStart Flu A&B Plus

Applicant: Access Bio, Inc.
Product code: PSZ
Advisory panel: Microbiology
Date received: 2019-06-07
Decision date: 2020-02-18
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Somerset, NJ, US

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