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510(k) K201494

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2020
Date Received
June 5, 2020
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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  • K182123 — ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (March 29, 2019)
  • K122809 — Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (June 17, 2013)

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