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510(k) K221871

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx by Healstone Biotech, Inc. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2022
Date Received
June 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Amphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Healstone Biotech, Inc.

  • K212418 — hCG One Step Pregnancy Test (June 30, 2022)
  • K191841 — Accurate Multi Panel Drug Urine Test Cup (August 7, 2019)

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