FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
K Number: K253567
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
22
Applicant Total
27
Review Days
36
Basic Information
- Device Name
- Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
- K Number
- K253567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- November 17, 2025
- Decision Date
- December 23, 2025
- Product Code
- NGL
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NGL | Test, Opiates, Over The Counter | FDA class 2 | Clinical Toxicology |
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Other Clearances by Healgen Scientific,, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Apr 13, 2026 | Substantially Equivalent |
| K253705 | Healgen® Accurate Oral Fluid Drug Test | Mar 16, 2026 | Substantially Equivalent |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | Feb 12, 2026 | Substantially Equivalent |
| K251800 | Healgen® URS Test Strips | Dec 23, 2025 | Substantially Equivalent |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Aug 15, 2025 | Substantially Equivalent |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Dec 17, 2024 | Substantially Equivalent |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | May 13, 2024 | Substantially Equivalent |
| K232377 | Healgen Rapid COVID-19 Antigen Test | Apr 19, 2024 | Substantially Equivalent |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Apr 12, 2024 | Substantially Equivalent |
| K231045 | Healgen URS Test Strips | Jun 16, 2023 | Substantially Equivalent |