FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
K Number: K251697
·
Decision Nov 26, 2025
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
85
Review Days
177
Basic Information
- Device Name
- Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- K Number
- K251697
- Device Class
- FDA class 1
- Clearance Type
- Dual Track
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ACON Laboratories, Inc.
- Date Received
- June 2, 2025
- Decision Date
- November 26, 2025
- Product Code
- GTY
- 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GTY), ordered by most recent decision date.
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SOFIA (R) STREP A+ FIA
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WONDFO RAPID STREP A TEST
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SOFIA STREP A FIA
FDA 510(k)
FDA Class 1
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Other Clearances by ACON Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K230828 | Flowflex COVID-19 Antigen Home Test | Nov 9, 2023 | 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 |