hCG One Step Pregnancy Test— 510(k) K212418

Name: FDA 510(k) clearance K212418
Creator: U.S. Food and Drug Administration
Published: 2022-06-30

Substantially Equivalent

Healstone Biotech, Inc.

FDA 510(k) clearance K212418 for hCG One Step Pregnancy Test, Substantially Equivalent on 2022-06-30. Applicant: Healstone Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Healstone Biotech, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2021-08-03
Decision date: 2022-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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