K201269

Substantially Equivalent

Accula Strep A Test

Applicant: Mesa Biotech, Inc.
Product code: PGX
Advisory panel: Microbiology
Date received: 2020-05-12
Decision date: 2020-11-09
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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