FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Flowflex COVID-19 Antigen Home Test
K Number: K230828
·
Decision Nov 9, 2023
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
13
Applicant Total
85
Review Days
227
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Basic Information
- Device Name
- Flowflex COVID-19 Antigen Home Test
- K Number
- K230828
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3984
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ACON Laboratories, Inc.
- Date Received
- March 27, 2023
- Decision Date
- November 9, 2023
- 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 |
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Other Clearances by ACON Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | Nov 26, 2025 | Substantially Equivalent |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | Oct 22, 2025 | Substantially Equivalent |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | Oct 10, 2025 | Substantially Equivalent |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | May 10, 2025 | Substantially Equivalent |
| K232715 | Distinct® Digital Pregnancy Test | May 31, 2024 | Substantially Equivalent |
| K233373 | Flowflex® Plus COVID-19 Home Test | Apr 19, 2024 | Substantially Equivalent |
| K193318 | Distinct® Early Detection Pregnancy Test | Aug 20, 2020 | Substantially Equivalent |
| K192175 | On Call Express II Blood Glucose Monitoring System | Oct 17, 2019 | Substantially Equivalent |
| K191038 | On Call Express Voice Blood Glucose Monitoring System | Jun 12, 2019 | Substantially Equivalent |
| K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | Oct 3, 2018 | Substantially Equivalent |