ACON Laboratories, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Flowflex® Plus Strep A Rapid Test Cassette, Flowflex Plus RSV + Flu A/B + COVID Home Test, On Call® Sure GK Blood Glucose & Ketone Monitoring System
85
Total
85
Cleared
0
Denied
FDA 510(k) Regulatory Record - ACON Laboratories, Inc. Chemistry ✕
45 devices
Cleared
Oct 10, 2025
On Call® Sure GK Blood Glucose & Ketone Monitoring System
Chemistry
270d
Cleared
May 31, 2024
Distinct® Digital Pregnancy Test
Chemistry
269d
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
Cleared
Mar 07, 2018
On Call Express Mobile Blood Glucose Monitoring System
Chemistry
42d
Cleared
Jul 11, 2017
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
Chemistry
218d
Cleared
Jul 06, 2017
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent...
Chemistry
128d
Cleared
Sep 05, 2015
On Call Express Pro Blood Glucose Monitoring System
Chemistry
85d
Cleared
May 11, 2015
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission...
Chemistry
243d
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