Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

103 results for "ACON Laboratories, Inc."
1–24 of 103
Cleared Nov 26, 2025
Flowflex® Plus Strep A Rapid Test Cassette
K251697 · GTY
ACON Laboratories, Inc.
Microbiology · 177d
Cleared Oct 22, 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test
K251749 · SCA
ACON Laboratories, Inc.
Microbiology · 138d
Cleared Oct 10, 2025
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · NBW
ACON Laboratories, Inc.
Chemistry · 270d
Cleared May 10, 2025
Flowflex Plus COVID-19 + Flu A/B Home Test
K250377 · SCA
ACON Laboratories, Inc.
Microbiology · 89d
Cleared May 31, 2024
Distinct® Digital Pregnancy Test
K232715 · LCX
ACON Laboratories, Inc.
Chemistry · 269d
Cleared Apr 19, 2024
Flowflex® Plus COVID-19 Home Test
K233373 · QYT
ACON Laboratories, Inc.
Microbiology · 200d
Cleared Nov 09, 2023
Flowflex COVID-19 Antigen Home Test
K230828 · QYT
ACON Laboratories, Inc.
Microbiology · 227d
Cleared Aug 20, 2020
Distinct® Early Detection Pregnancy Test
K193318 · LCX
ACON Laboratories, Inc.
Chemistry · 262d
Cleared Oct 17, 2019
On Call Express II Blood Glucose Monitoring System
K192175 · NBW
ACON Laboratories, Inc.
Chemistry · 66d
Cleared Jun 12, 2019
On Call Express Voice Blood Glucose Monitoring System
K191038 · NBW
ACON Laboratories, Inc.
Chemistry · 55d
Cleared Oct 03, 2018
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose...
K181527 · NBW
ACON Laboratories, Inc.
Chemistry · 114d
Cleared Mar 28, 2018
Mission Lipid Panel Monitoring System
K180504 · CHH
ACON Laboratories, Inc.
Chemistry · 30d
Cleared Mar 07, 2018
On Call Express Mobile Blood Glucose Monitoring System
K180196 · NBW
ACON Laboratories, Inc.
Chemistry · 42d
Cleared Jul 11, 2017
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406 · CHH
ACON Laboratories, Inc.
Chemistry · 218d
Cleared Jul 06, 2017
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent...
K170587 · JIN
ACON Laboratories, Inc.
Chemistry · 128d
Cleared Sep 05, 2015
On Call Express Pro Blood Glucose Monitoring System
K151595 · NBW
ACON Laboratories, Inc.
Chemistry · 85d
Cleared May 11, 2015
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission...
K142543 · KQO
ACON Laboratories, Inc.
Chemistry · 243d
Cleared Apr 30, 2015
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
K150330 · JIR
ACON Laboratories, Inc.
Chemistry · 79d
Cleared Dec 22, 2014
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (...
K142391 · JFY
ACON Laboratories, Inc.
Chemistry · 117d
Cleared Jan 06, 2014
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
K131469 · NBW
ACON Laboratories, Inc.
Chemistry · 230d
Cleared Dec 20, 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · NBW
ACON Laboratories, Inc.
Chemistry · 318d
Cleared Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · NBW
ACON Laboratories, Inc.
Chemistry · 167d
Cleared Aug 05, 2013
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · GKR
ACON Laboratories, Inc.
Hematology · 349d
Cleared Dec 14, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010 · NBW
ACON Laboratories, Inc.
Chemistry · 78d