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510(k) K191841

Accurate Multi Panel Drug Urine Test Cup by Healstone Biotech, Inc. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2019
Date Received
July 9, 2019
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.

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