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ACON Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories7
Latest FDA decision2026-07-10
TypeNumberDevice NameCodeDateActions
510(k) K261212 Flowflex Plus RSV + Flu A/B + COVID Rapid TestSCA2026-07-10 View
510(k) K251697 Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY2025-11-26 View
510(k) K251749 Flowflex Plus RSV + Flu A/B + COVID Home TestSCA2025-10-22 View
510(k) K250085 On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemNBW2025-10-10 View
510(k) K250377 Flowflex Plus COVID-19 + Flu A/B Home TestSCA2025-05-10 View
510(k) K232715 Distinct® Digital Pregnancy TestLCX2024-05-31 View
510(k) K233373 Flowflex® Plus COVID-19 Home TestQYT2024-04-19 View
510(k) K230828 Flowflex COVID-19 Antigen Home TestQYT2023-11-09 View
510(k) K193318 Distinct® Early Detection Pregnancy TestLCX2020-08-20 View
510(k) K192175 On Call Express II Blood Glucose Monitoring SystemNBW2019-10-17 View
510(k) K191038 On Call Express Voice Blood Glucose Monitoring SystemNBW2019-06-12 View
510(k) K181527 On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring SystemNBW2018-10-03 View
510(k) K180504 Mission Lipid Panel Monitoring SystemCHH2018-03-28 View
510(k) K180196 On Call Express Mobile Blood Glucose Monitoring SystemNBW2018-03-07 View
510(k) K163406 Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH2017-07-11 View
510(k) K170587 On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisJIN2017-07-06 View
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