Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup— 510(k) K243365
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K243365 for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup, Substantially Equivalent on 2024-12-17. Applicant: Healgen Scientific,, LLC. Device class: 2.
Clearance details
- Applicant
- Healgen Scientific,, LLC
- Product code
- Code NGL
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code NGL
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- K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
More clearances from Healgen Scientific,, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.