| Flowflex Plus RSV + Flu A/B + COVID Rapid Test (K261212) | ACON Laboratories, Inc. | 2026-07-10 |
| Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip (K251697) | ACON Laboratories, Inc. | 2025-11-26 |
| Flowflex Plus RSV + Flu A/B + COVID Home Test (K251749) | ACON Laboratories, Inc. | 2025-10-22 |
| On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (K250085) | ACON Laboratories, Inc. | 2025-10-10 |
| Flowflex Plus COVID-19 + Flu A/B Home Test (K250377) | ACON Laboratories, Inc. | 2025-05-10 |
| Distinct® Digital Pregnancy Test (K232715) | ACON Laboratories, Inc. | 2024-05-31 |
| Flowflex® Plus COVID-19 Home Test (K233373) | ACON Laboratories, Inc. | 2024-04-19 |
| Flowflex COVID-19 Antigen Home Test (K230828) | ACON Laboratories, Inc. | 2023-11-09 |
| Distinct® Early Detection Pregnancy Test (K193318) | ACON Laboratories, Inc. | 2020-08-20 |
| On Call Express II Blood Glucose Monitoring System (K192175) | ACON Laboratories, Inc. | 2019-10-17 |
| On Call Express Voice Blood Glucose Monitoring System (K191038) | ACON Laboratories, Inc. | 2019-06-12 |
| On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System (K181527) | ACON Laboratories, Inc. | 2018-10-03 |
| Mission Lipid Panel Monitoring System (K180504) | ACON Laboratories, Inc. | 2018-03-28 |
| On Call Express Mobile Blood Glucose Monitoring System (K180196) | ACON Laboratories, Inc. | 2018-03-07 |
| Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (K163406) | ACON Laboratories, Inc. | 2017-07-11 |
| On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis (K170587) | ACON Laboratories, Inc. | 2017-07-06 |
| On Call Express Pro Blood Glucose Monitoring System (K151595) | ACON Laboratories, Inc. | 2015-09-05 |
| Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control (K142543) | ACON Laboratories, Inc. | 2015-05-11 |
| Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K150330) | ACON Laboratories, Inc. | 2015-04-30 |
| Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (K142391) | ACON Laboratories, Inc. | 2014-12-22 |
| ACON ON CALL DIABETES MANAGEMENT SOFTWARE (K131469) | ACON Laboratories, Inc. | 2014-01-06 |
| ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM (K130284) | ACON Laboratories, Inc. | 2013-12-20 |
| ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM (K132086) | ACON Laboratories, Inc. | 2013-12-19 |
| MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM (K122553) | ACON Laboratories, Inc. | 2013-08-05 |
| ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM (K123010) | ACON Laboratories, Inc. | 2012-12-14 |
| ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM (K122110) | ACON Laboratories, Inc. | 2012-11-21 |
| ON CALL CHOSEN LANCING DEVICE (K113332) | ACON Laboratories, Inc. | 2012-04-18 |
| ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS (K112653) | ACON Laboratories, Inc. | 2012-04-09 |
| FORESIGHT U120 URINE ANALYZER (K120124) | ACON Laboratories, Inc. | 2012-03-06 |
| MISSION U500 URINE ANALYZER (K111221) | ACON Laboratories, Inc. | 2012-01-18 |
| ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM (K111371) | ACON Laboratories, Inc. | 2011-10-06 |
| MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL (K103387) | ACON Laboratories, Inc. | 2011-02-02 |
| ON CALL PLUS DIABETES MONITORING SOFTWARE (K101371) | ACON Laboratories, Inc. | 2011-01-07 |
| MISSION SALIVA ALCOHOL TEST STRIP (K093879) | ACON Laboratories, Inc. | 2010-08-06 |
| MISSION BREATH ALCOHOL DETECTOR (K093143) | ACON Laboratories, Inc. | 2010-01-28 |
| ACON UTI URINARY TRACT INFECTION TEST STRIPS (K063295) | ACON Laboratories, Inc. | 2007-10-12 |
| ACON U120 URINE ANALYZER, MODEL U111-101 (K070929) | ACON Laboratories, Inc. | 2007-07-30 |
| ACON DIGITAL THERMOMETER PROBE COVERS (K063418) | ACON Laboratories, Inc. | 2007-02-02 |
| ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 (K060925) | ACON Laboratories, Inc. | 2006-05-09 |
| ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE (K060466) | ACON Laboratories, Inc. | 2006-04-21 |
| ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS (K060173) | ACON Laboratories, Inc. | 2006-03-17 |
| ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE (K050936) | ACON Laboratories, Inc. | 2005-06-24 |
| ON CALL MULTI-DRUG HOME TEST CUP (K050878) | ACON Laboratories, Inc. | 2005-06-08 |
| ACON +/- MIDSTREAM PREGNANCY TEST (K050546) | ACON Laboratories, Inc. | 2005-05-20 |
| ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE (K050593) | ACON Laboratories, Inc. | 2005-05-06 |
| ON CALL MULTI-DRUG HOME TEST (K050050) | ACON Laboratories, Inc. | 2005-03-11 |
| ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (K042272) | ACON Laboratories, Inc. | 2005-02-28 |
| ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE (K043507) | ACON Laboratories, Inc. | 2005-02-25 |
| ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE (K041822) | ACON Laboratories, Inc. | 2004-09-16 |
| ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST (K042151) | ACON Laboratories, Inc. | 2004-09-09 |
| ACON TRI-FECT DRUG SCREEN TEST DEVICE (K041743) | ACON Laboratories, Inc. | 2004-09-09 |
| ACON MULTI-CLIN DRUG SCREEN TEST DEVICE (K041685) | ACON Laboratories, Inc. | 2004-08-30 |
| ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE (K041946) | ACON Laboratories, Inc. | 2004-08-16 |
| FSH MENOPAUSE PREDICTOR TEST (K041165) | ACON Laboratories, Inc. | 2004-06-17 |
| ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE (K040445) | ACON Laboratories, Inc. | 2004-05-19 |
| ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE (K040274) | ACON Laboratories, Inc. | 2004-05-03 |
| ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE (K032903) | ACON Laboratories, Inc. | 2004-02-17 |
| ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE (K033047) | ACON Laboratories, Inc. | 2004-02-17 |
| ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE (K033299) | ACON Laboratories, Inc. | 2003-12-12 |
| ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP (K033041) | ACON Laboratories, Inc. | 2003-11-21 |
| ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) (K032661) | ACON Laboratories, Inc. | 2003-10-14 |
| ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST (K032510) | ACON Laboratories, Inc. | 2003-09-22 |
| ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD (K031759) | ACON Laboratories, Inc. | 2003-08-04 |
| ACON STREP A RAPID TEST DEVICE (K031784) | ACON Laboratories, Inc. | 2003-07-14 |
| ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE (K024350) | ACON Laboratories, Inc. | 2003-04-02 |
| ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE (K023946) | ACON Laboratories, Inc. | 2003-02-05 |
| ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE (K022589) | ACON Laboratories, Inc. | 2002-10-28 |
| ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (K021526) | ACON Laboratories, Inc. | 2002-07-17 |
| ACON ONE STEP DRUG SCREEN TEST CARD (K020771) | ACON Laboratories, Inc. | 2002-05-15 |
| ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE (K013380) | ACON Laboratories, Inc. | 2001-12-18 |
| ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE (K012824) | ACON Laboratories, Inc. | 2001-11-09 |
| ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE (K012595) | ACON Laboratories, Inc. | 2001-10-15 |
| ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE (K012300) | ACON Laboratories, Inc. | 2001-09-17 |
| QUIK-CHECK OVULATION PREDICTOR (K012252) | ACON Laboratories, Inc. | 2001-08-24 |
| ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE (K011730) | ACON Laboratories, Inc. | 2001-08-09 |
| QUIK-CHECK HOME PREGNANCY TEST (K012215) | ACON Laboratories, Inc. | 2001-08-07 |
| ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE (K011673) | ACON Laboratories, Inc. | 2001-07-31 |
| ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE (K011672) | ACON Laboratories, Inc. | 2001-07-31 |
| ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE (K011353) | ACON Laboratories, Inc. | 2001-07-30 |
| ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE (K010841) | ACON Laboratories, Inc. | 2001-07-09 |
| ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) (K003557) | ACON Laboratories, Inc. | 2001-03-15 |
| ACON ONE STEP HOME PREGNANCY TEST STRIP (K993483) | ACON Laboratories, Inc. | 2000-01-20 |
| ACON ONE STEP PREGNANCY TEST STRIP (URINE) (K993203) | ACON Laboratories, Inc. | 1999-12-01 |
| ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) (K993317) | ACON Laboratories, Inc. | 1999-12-01 |
| ACON COMBO PREGNANCY (K993065) | ACON Laboratories, Inc. | 1999-10-08 |
| ACON MIDSTREAM PREGNANCY TEST (K983090) | ACON Laboratories, Inc. | 1998-11-18 |