TruDiagnosis System— 510(k) K183530

Substantially Equivalent

Akonni Biosystems, Inc.

FDA 510(k) clearance K183530 for TruDiagnosis System, Substantially Equivalent on 2019-05-24. Applicant: Akonni Biosystems, Inc..

Clearance details

Applicant
Akonni Biosystems, Inc.
Product code
Code ODW
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Frederick, MD, US
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