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510(k) K253082

LZI Buprenorphine II Enzyme Immunoassay by Lin-Zhi International, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2026
Date Received
September 23, 2025
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

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