Source document or public record
FDA 510(k) K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
FDA 510(k) index record K242802. Device: CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd.. Decision date: 2024-11-08.
Source
"device_name": "CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl 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 K242802.
Device name: CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd..
Decision date: 2024-11-08. 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.
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