Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard— 510(k) K231904

Substantially Equivalent

Co-Innovation Biotech Co., Ltd.

FDA 510(k) clearance K231904 for Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard, Substantially Equivalent on 2024-03-08. Applicant: Co-Innovation Biotech Co., Ltd..

Clearance details

Applicant: Co-Innovation Biotech Co., Ltd.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2023-06-28
Decision date: 2024-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

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