LZI Buprenorphine II Enzyme Immunoassay— 510(k) K253082

Substantially Equivalent

Lin-Zhi International, Inc.

FDA 510(k) clearance K253082 for LZI Buprenorphine II Enzyme Immunoassay, Substantially Equivalent on 2026-01-16. Applicant: Lin-Zhi International, Inc..

Clearance details

Applicant: Lin-Zhi International, Inc.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2025-09-23
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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