Healgen® Accurate Oral Fluid Drug Test COT/THC— 510(k) K252523
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K252523 for Healgen® Accurate Oral Fluid Drug Test COT/THC, Substantially Equivalent on 2026-02-12. Applicant: Healgen Scientific,, LLC. Device class: 2.
Clearance details
- Device name as filed
- Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
- Applicant
- Healgen Scientific,, LLC
- Product code
- Code NFW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- 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.