ACON Laboratories, Inc. - FDA 510(k) Cleared Devices
85
Total
85
Cleared
0
Denied
ACON Laboratories, Inc. has 85 FDA 510(k) cleared medical devices. Based in San Diego, US.
Latest FDA clearance: Nov 2025. Active since 1998. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by ACON Laboratories, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by ACON Laboratories, Inc.
85 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
Oct 10, 2025
On Call® Sure GK Blood Glucose & Ketone Monitoring System
Chemistry
270d
Cleared
May 10, 2025
Flowflex Plus COVID-19 + Flu A/B Home Test
Microbiology
89d
Cleared
May 31, 2024
Distinct® Digital Pregnancy Test
Chemistry
269d
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
Aug 20, 2020
Distinct® Early Detection Pregnancy Test
Chemistry
262d
Cleared
Oct 17, 2019
On Call Express II Blood Glucose Monitoring System
Chemistry
66d
Cleared
Jun 12, 2019
On Call Express Voice Blood Glucose Monitoring System
Chemistry
55d
Cleared
Oct 03, 2018
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose...
Chemistry
114d
Cleared
Mar 28, 2018
Mission Lipid Panel Monitoring System
Chemistry
30d
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