510(k) K212418— hCG One Step Pregnancy Test

Substantially Equivalent

Healstone Biotech, Inc.

Clearance details

Applicant: Healstone Biotech, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2021-08-03
Decision date: 2022-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

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