Medical Device Manufacturer · US , San Diego , CA

ACON Laboratories, Inc.

85 submissions · 85 cleared · Since 1998
85
Total
85
Cleared
0
Denied

ACON Laboratories, Inc. — FDA 510(k) Submissions

ACON Laboratories, Inc. has submitted 85 FDA 510(k) premarket notifications since 1998, of which 85 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Blood Glucose, Over The Counter, Kit, Test, Pregnancy, Hcg, Over The Counter, Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Amphetamine, Visual, Pregnancy Hcg, Prescription Use . Use the specialty filter in the sidebar to narrow results.

85 devices
1–25 of 85
Flowflex? Plus Strep A Rapid Test Cassette; Flowflex? Plus Strep A Rapid Test Strip
K251697 · GTY Antigens, All Groups,... · Microbiology
Nov 2025 177d
Flowflex Plus RSV + Flu A/B + COVID Home Test
K251749 · SCA Multi-analyte Respiratory... · Microbiology
Oct 2025 138d
On Call? Sure GK Blood Glucose & Ketone Monitoring System; On Call? Sure Sync GK Blood Glucose & Ketone Monitoring System
K250085 · NBW System, Test, Blood... · Chemistry
Oct 2025 270d
Flowflex Plus COVID-19 + Flu A/B Home Test
K250377 · SCA Multi-analyte Respiratory... · Microbiology
May 2025 89d
Distinct? Digital Pregnancy Test
K232715 · LCX Kit, Test, Pregnancy,... · Chemistry
May 2024 269d
Flowflex? Plus COVID-19 Home Test
K233373 · QYT Over-the-counter Covid-19... · Microbiology
Apr 2024 200d
Flowflex COVID-19 Antigen Home Test
K230828 · QYT Over-the-counter Covid-19... · Microbiology
Nov 2023 227d
Distinct? Early Detection Pregnancy Test
K193318 · LCX Kit, Test, Pregnancy,... · Chemistry
Aug 2020 262d
On Call Express II Blood Glucose Monitoring System
K192175 · NBW System, Test, Blood... · Chemistry
Oct 2019 66d
On Call Express Voice Blood Glucose Monitoring System
K191038 · NBW System, Test, Blood... · Chemistry
Jun 2019 55d
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
K181527 · NBW System, Test, Blood... · Chemistry
Oct 2018 114d
Mission Lipid Panel Monitoring System
K180504 · CHH Enzymatic... · Chemistry
Mar 2018 30d
On Call Express Mobile Blood Glucose Monitoring System
K180196 · NBW System, Test, Blood... · Chemistry
Mar 2018 42d
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406 · CHH Enzymatic... · Chemistry
Jul 2017 218d
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
K170587 · JIN Nitroprusside, Ketones... · Chemistry
Jul 2017 128d
On Call Express Pro Blood Glucose Monitoring System
K151595 · NBW System, Test, Blood... · Chemistry
Sep 2015 85d
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
K142543 · KQO Automated Urinalysis System · Chemistry
May 2015 243d
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
K150330 · JIR Indicator Method, Protein... · Chemistry
Apr 2015 79d
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
K142391 · JFY Enzymatic Method, Creatinine · Chemistry
Dec 2014 117d
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
K131469 · NBW System, Test, Blood... · Chemistry
Jan 2014 230d
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · NBW System, Test, Blood... · Chemistry
Dec 2013 318d
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · NBW System, Test, Blood... · Chemistry
Dec 2013 167d
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · GKR System, Hemoglobin,... · Hematology
Aug 2013 349d
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010 · NBW System, Test, Blood... · Chemistry
Dec 2012 78d
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
K122110 · CGA Glucose Oxidase, Glucose · Chemistry
Nov 2012 127d

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