Source document or public record
FDA 510(k) K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
FDA 510(k) index record K240654. Device: SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd.. Decision date: 2024-04-10.
Source
"device_name": "SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K240654.
Device name: SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd..
Decision date: 2024-04-10. Decision wording: Substantially Equivalent.
Product code: NGL. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.