Healgen® Accurate Oral Fluid Drug Test— 510(k) K253705
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K253705 for Healgen® Accurate Oral Fluid Drug Test, Substantially Equivalent on 2026-03-16. Applicant: Healgen Scientific,, LLC. Device class: 2.
Summary
Healgen Scientific's Healgen® Accurate Oral Fluid Drug Test is filed under DJC, methamphetamine thin layer chromatography tests. The record doesn't describe the test beyond its name and that code name.
Class II, 21 CFR 862.3610. Clinical Toxicology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Healgen Scientific filed from Houston, Texas. Review took 112 calendar days (November 24, 2025 to March 16, 2026).
Clearance details
- Applicant
- Healgen Scientific,, LLC
- Product code
- Product code DJC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.