Source document or public record
FDA 510(k) K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
FDA 510(k) index record K231904. Device: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard. Applicant as listed: Co-Innovation Biotech Co., Ltd.. Decision date: 2024-03-08.
Source
"device_name": "Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K231904.
Device name: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard. Applicant as listed: Co-Innovation Biotech Co., Ltd..
Decision date: 2024-03-08. Decision wording: Substantially Equivalent.
Product code: DJG. Regulation: 21 CFR 862.3650. Medical specialty: Clinical Toxicology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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