FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Healgen URS Test Strips
K Number: K231045
·
Decision Jun 16, 2023
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
6
Applicant Total
27
Review Days
65
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Basic Information
- Device Name
- Healgen URS Test Strips
- K Number
- K231045
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.7675
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- April 12, 2023
- Decision Date
- June 16, 2023
- Product Code
- LJX
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LJX | Test, Urine Leukocyte | FDA class 1 | Hematology |
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Other Clearances by Healgen Scientific,, LLC
| K Number | Device Name | ||
|---|---|---|---|
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| K251800 | Healgen® URS Test Strips | Dec 23, 2025 | Substantially Equivalent |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | 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 |