Source document or public record
FDA 510(k) K252523 — Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
FDA 510(k) index record K252523. Device: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2026-02-12.
Source
"device_name": "Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test"
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 K252523.
Device name: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test. Applicant as listed: Healgen Scientific,, LLC.
Decision date: 2026-02-12. Decision wording: Substantially Equivalent.
Product code: NFW. Regulation: 21 CFR 862.3870. 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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