FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Heal-Check Rapid COVID-19 Antigen Self-Test
K Number: K260095
·
Decision Apr 13, 2026
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
13
Applicant Total
27
Review Days
90
Basic Information
- Device Name
- Heal-Check Rapid COVID-19 Antigen Self-Test
- K Number
- K260095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3984
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- January 13, 2026
- Decision Date
- April 13, 2026
- Product Code
- QYT
- 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 |
|---|---|---|---|
| QYT | Over-The-Counter Covid-19 Antigen Test | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QYT), ordered by most recent decision date.
Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
FDA 510(k)
FDA Class 2
·Microbiology
GenBody COVID-19 Ag Home Test
FDA 510(k)
FDA Class 2
·Microbiology
COVID-19 Detect Rapid Self -Test
FDA 510(k)
FDA Class 2
·Microbiology
GenaCheck COVID-19 Rapid Self-Test
FDA 510(k)
FDA Class 2
·Microbiology
OHC COVID-19 Antigen Self Test
FDA 510(k)
FDA Class 2
·Microbiology
BinaxNOW COVID-19 Antigen Self Test
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Healgen Scientific,, LLC
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |