ACON Laboratories, Inc. - FDA 510(k) Cleared Devices
85
Total
85
Cleared
0
Denied
FDA 510(k) cleared devices by ACON Laboratories, Inc. Microbiology ✕
7 devices
Cleared
Nov 26, 2025
Flowflex® Plus Strep A Rapid Test Cassette
Microbiology
177d
Cleared
Oct 22, 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test
Microbiology
138d
Cleared
May 10, 2025
Flowflex Plus COVID-19 + Flu A/B Home Test
Microbiology
89d
Cleared
Apr 19, 2024
Flowflex® Plus COVID-19 Home Test
Microbiology
200d
Cleared
Nov 09, 2023
Flowflex COVID-19 Antigen Home Test
Microbiology
227d
Cleared
Jul 14, 2003
ACON STREP A RAPID TEST DEVICE
Microbiology
34d
Cleared
Apr 02, 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
Microbiology
93d