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510(k) K182123

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card by Advin Biotech, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2019
Date Received
August 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Advin Biotech, Inc.

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  • K122809 — Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (June 17, 2013)

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