Company · US
ACON Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
93510(k) clearances (2 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 13 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 10 |
| DJG | Enzyme Immunoassay, Opiates | 6 |
| DKZ | Enzyme Immunoassay, Amphetamine | 6 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 4 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 4 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 |
| LAF | Gas Chromatography, Methamphetamine | 3 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 3 |
| CGA | Glucose Oxidase, Glucose | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| DJZ | Devices, Breath Trapping, Alcohol | 2 |
| FLL | Continuous Measurement Thermometer | 2 |
| KQO | Automated Urinalysis System | 2 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 2 |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2026 | K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test ACON Laboratories, Inc. | SCA |
| Nov 26, 2025 | K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip ACON Laboratories, Inc. | GTY |
| Oct 22, 2025 | K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test ACON Laboratories, Inc. | SCA |
| Oct 10, 2025 | K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring Syste ACON Laboratories, Inc. | NBW |
| May 10, 2025 | K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test ACON Laboratories, Inc. | SCA |
| May 31, 2024 | K232715 | Distinct® Digital Pregnancy Test ACON Laboratories, Inc. | LCX |
| Apr 19, 2024 | K233373 | Flowflex® Plus COVID-19 Home Test ACON Laboratories, Inc. | QYT |
| Nov 9, 2023 | K230828 | Flowflex COVID-19 Antigen Home Test ACON Laboratories, Inc. | QYT |
| Aug 20, 2020 | K193318 | Distinct® Early Detection Pregnancy Test ACON Laboratories, Inc. | LCX |
| Oct 17, 2019 | K192175 | On Call Express II Blood Glucose Monitoring System ACON Laboratories, Inc. | NBW |
| Jun 12, 2019 | K191038 | On Call Express Voice Blood Glucose Monitoring System ACON Laboratories, Inc. | NBW |
| Oct 3, 2018 | K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System ACON Laboratories, Inc. | NBW |
| Mar 28, 2018 | K180504 | Mission Lipid Panel Monitoring System ACON Laboratories, Inc. | CHH |
| Mar 7, 2018 | K180196 | On Call Express Mobile Blood Glucose Monitoring System ACON Laboratories, Inc. | NBW |
| Jul 11, 2017 | K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System ACON Laboratories, Inc. | CHH |
| Jul 6, 2017 | K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis ACON Laboratories, Inc. | JIN |
| Aug 5, 2016 | K161867 | On Call Pro Blood Glucose Monitoring System Acon Laboratories | NBW |
| Sep 5, 2015 | K151595 | On Call Express Pro Blood Glucose Monitoring System ACON Laboratories, Inc. | NBW |
| May 11, 2015 | K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control ACON Laboratories, Inc. | KQO |
| Apr 30, 2015 | K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) ACON Laboratories, Inc. | JIR |
| Dec 22, 2014 | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) ACON Laboratories, Inc. | JFY |
| Jan 6, 2014 | K131469 | ACON ON CALL DIABETES MANAGEMENT SOFTWARE ACON Laboratories, Inc. | NBW |
| Dec 20, 2013 | K130284 | ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. | NBW |
| Dec 19, 2013 | K132086 | ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. | NBW |
| Aug 5, 2013 | K122553 | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM ACON Laboratories, Inc. | GKR |
| Dec 14, 2012 | K123010 | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. | NBW |
| Nov 21, 2012 | K122110 | ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. | CGA |
| Apr 18, 2012 | K113332 | ON CALL CHOSEN LANCING DEVICE ACON Laboratories, Inc. | FMK |
| Apr 9, 2012 | K112653 | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS ACON Laboratories, Inc. | JJX |
| Mar 6, 2012 | K120124 | FORESIGHT U120 URINE ANALYZER ACON Laboratories, Inc. | JIL |
| Jan 18, 2012 | K111221 | MISSION U500 URINE ANALYZER ACON Laboratories, Inc. | JIO |
| Oct 6, 2011 | K111371 | ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. | CGA |
| Feb 2, 2011 | K103387 | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL ACON Laboratories, Inc. | JJW |
| Jan 7, 2011 | K101371 | ON CALL PLUS DIABETES MONITORING SOFTWARE ACON Laboratories, Inc. | NBW |
| Aug 6, 2010 | K093879 | MISSION SALIVA ALCOHOL TEST STRIP ACON Laboratories, Inc. | DIC |
| Jan 28, 2010 | K093143 | MISSION BREATH ALCOHOL DETECTOR ACON Laboratories, Inc. | DJZ |
| Apr 8, 2009 | K090057 | ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories Co. | NBW |
| Oct 12, 2007 | K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS ACON Laboratories, Inc. | LJX |
| Jul 30, 2007 | K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 ACON Laboratories, Inc. | KQO |
| Feb 2, 2007 | K063418 | ACON DIGITAL THERMOMETER PROBE COVERS ACON Laboratories, Inc. | FLL |
| Aug 11, 2006 | K061559 | ACON URINALYSIS REAGENT STRIPS Acon Laboratories Co. | CDM |
| May 9, 2006 | K060925 | ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 ACON Laboratories, Inc. | DXN |
| Apr 21, 2006 | K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE ACON Laboratories, Inc. | DJG |
| Mar 17, 2006 | K060173 | ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS ACON Laboratories, Inc. | FLL |
| Jun 24, 2005 | K050936 | ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE ACON Laboratories, Inc. | LDJ |
| Jun 8, 2005 | K050878 | ON CALL MULTI-DRUG HOME TEST CUP ACON Laboratories, Inc. | LDJ |
| May 20, 2005 | K050546 | ACON +/- MIDSTREAM PREGNANCY TEST ACON Laboratories, Inc. | LCX |
| May 6, 2005 | K050593 | ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE ACON Laboratories, Inc. | DIS |
| Mar 11, 2005 | K050050 | ON CALL MULTI-DRUG HOME TEST ACON Laboratories, Inc. | LDJ |
| Feb 28, 2005 | K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) ACON Laboratories, Inc. | KTN |
Newest 50 of 93.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2015 | Acon Laboratories, Inc. Mission
-Breath Alcohol Detector
-15 tests
- 0.08% BAC
- Blow bags included
Product Usage:
The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the Terminated |
DJZ | K093143 |