FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Healgen Rapid COVID-19 Antigen Test
K Number: K232377
·
Decision Apr 19, 2024
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
27
Review Days
255
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Basic Information
- Device Name
- Healgen Rapid COVID-19 Antigen Test
- K Number
- K232377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3982
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- August 8, 2023
- Decision Date
- April 19, 2024
- Product Code
- QVF
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | FDA class 2 | Microbiology |
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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 |
| 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 |
| 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 |