KET-1 Blood Ketone Monitoring System— 510(k) K182593

Substantially Equivalent

Apex BioTechnology Corp.

FDA 510(k) clearance K182593 for KET-1 Blood Ketone Monitoring System, Substantially Equivalent on 2018-12-18. Applicant: Apex BioTechnology Corp..

Clearance details

Applicant: Apex BioTechnology Corp.
Product code: Code JIN
Advisory panel: Clinical Chemistry
Date received: 2018-09-20
Decision date: 2018-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

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