Acon Laboratories, Inc.
San Diego, CA, US
ACON LABORATORIES, INC. appears in FDA device records in San Diego, CA. FDA records list 93 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 93FDA records hold 93 510(k) clearances for Acon Laboratories, Inc. between 1998 and 2026. The busiest year on record is 2001, with 13. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 13 |
| 2002 | 4 |
| 2003 | 9 |
| 2004 | 10 |
| 2005 | 7 |
| 2006 | 4 |
| 2007 | 3 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 6 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 4 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | SCA | Substantially Equivalent | |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | GTY | Substantially Equivalent | |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | SCA | Substantially Equivalent | |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | NBW | Substantially Equivalent | |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | SCA | Substantially Equivalent | |
| K232715 | Distinct® Digital Pregnancy Test | LCX | Substantially Equivalent | |
| K233373 | Flowflex® Plus COVID-19 Home Test | QYT | Substantially Equivalent | |
| K230828 | Flowflex COVID-19 Antigen Home Test | QYT | Substantially Equivalent | |
| K193318 | Distinct® Early Detection Pregnancy Test | LCX | Substantially Equivalent | |
| K192175 | On Call Express II Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K191038 | On Call Express Voice Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K180504 | Mission Lipid Panel Monitoring System | CHH | Substantially Equivalent | |
| K180196 | On Call Express Mobile Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | CHH | Substantially Equivalent | |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis | JIN | Substantially Equivalent | |
| K161867 | On Call Pro Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K151595 | On Call Express Pro Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control | KQO | Substantially Equivalent | |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | JIR | Substantially Equivalent | |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | JFY | Substantially Equivalent | |
| K131469 | ACON ON CALL DIABETES MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | |
| K130284 | ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K132086 | ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K122553 | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM | GKR | Substantially Equivalent | |
| K123010 | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K122110 | ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K113332 | ON CALL CHOSEN LANCING DEVICE | FMK | Substantially Equivalent | |
| K112653 | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS | JJX | Substantially Equivalent | |
| K120124 | FORESIGHT U120 URINE ANALYZER | JIL | Substantially Equivalent | |
| K111221 | MISSION U500 URINE ANALYZER | JIO | Substantially Equivalent | |
| K111371 | ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K103387 | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL | JJW | Substantially Equivalent | |
| K101371 | ON CALL PLUS DIABETES MONITORING SOFTWARE | NBW | Substantially Equivalent | |
| K093879 | MISSION SALIVA ALCOHOL TEST STRIP | DIC | Substantially Equivalent | |
| K093143 | MISSION BREATH ALCOHOL DETECTOR | DJZ | Substantially Equivalent | |
| K090057 | ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | LJX | Substantially Equivalent | |
| K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 | KQO | Substantially Equivalent | |
| K063418 | ACON DIGITAL THERMOMETER PROBE COVERS | FLL | Substantially Equivalent | |
| K061559 | ACON URINALYSIS REAGENT STRIPS | CDM | Substantially Equivalent | |
| K060925 | ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 | DXN | Substantially Equivalent | |
| K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE | DJG | Substantially Equivalent | |
| K060173 | ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS | FLL | Substantially Equivalent | |
| K050936 | ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE | LDJ | Substantially Equivalent | |
| K050878 | ON CALL MULTI-DRUG HOME TEST CUP | LDJ | Substantially Equivalent | |
| K050546 | ACON +/- MIDSTREAM PREGNANCY TEST | LCX | Substantially Equivalent | |
| K050593 | ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE | DIS | Substantially Equivalent | |
| K050050 | ON CALL MULTI-DRUG HOME TEST | LDJ | Substantially Equivalent | |
| K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | KTN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2531491 | 3003516723 | ACON LABORATORIES, INC. | 9440 Carroll Park Dr, SAN DIEGO, CA 92121 US | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- GTYAntigens, All Groups, Streptococcus Spp.
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JQPCalculator/Data Processing Module, For Clinical Use
- JGYColorimetric Method, Triglycerides
- FLLContinuous Measurement Thermometer
- GGMControl, Hemoglobin
- QMNCovid-19 Multi-Analyte Antigen Device
- DJZDevices, Breath Trapping, Alcohol
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LAFGas Chromatography, Methamphetamine
- CGAGlucose Oxidase, Glucose
- LYRHelicobacter Pylori
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LBRLdl & Vldl Precipitation, Hdl
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- QYTOver-The-Counter Covid-19 Antigen Test
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- JRERefractometer For Clinical Use
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- GKRSystem, Hemoglobin, Automated
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- NBWSystem, Test, Blood Glucose, Over The Counter
- KTNSystem, Test, Infectious Mononucleosis
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- NGJTest, Nitrite, Urinary, Non-Quantitative, Over The Counter
- LJXTest, Urine Leukocyte
- JJWUrinalysis Controls (Assayed And Unassayed)
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2322-2015 | 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 exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels. | Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. | Class III | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain