FDA 510(k) Applications Submitted by ACON LABORATORIES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K113332 |
11/14/2011 |
ON CALL CHOSEN LANCING DEVICE |
ACON LABORATORIES, INC. |
| K050050 |
01/10/2005 |
ON CALL MULTI-DRUG HOME TEST |
ACON LABORATORIES, INC. |
| K060173 |
01/23/2006 |
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS |
ACON LABORATORIES, INC. |
| K040274 |
02/05/2004 |
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE |
ACON LABORATORIES, INC. |
| K040445 |
02/20/2004 |
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE |
ACON LABORATORIES, INC. |
| K060466 |
02/22/2006 |
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE |
ACON LABORATORIES, INC. |
| K050546 |
03/02/2005 |
ACON +/- MIDSTREAM PREGNANCY TEST |
ACON LABORATORIES, INC. |
| K020771 |
03/08/2002 |
ACON ONE STEP DRUG SCREEN TEST CARD |
ACON LABORATORIES, INC. |
| K050593 |
03/08/2005 |
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE |
ACON LABORATORIES, INC. |
| K060925 |
04/04/2006 |
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 |
ACON LABORATORIES, INC. |
| K050878 |
04/06/2005 |
ON CALL MULTI-DRUG HOME TEST CUP |
ACON LABORATORIES, INC. |
| K050936 |
04/14/2005 |
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE |
ACON LABORATORIES, INC. |
| K011353 |
05/03/2001 |
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE |
ACON LABORATORIES, INC. |
| K021526 |
05/10/2002 |
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE |
ACON LABORATORIES, INC. |
| K011672 |
05/30/2001 |
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE |
ACON LABORATORIES, INC. |
| K011673 |
05/30/2001 |
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE |
ACON LABORATORIES, INC. |
| K011730 |
06/05/2001 |
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE |
ACON LABORATORIES, INC. |
| K031759 |
06/06/2003 |
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD |
ACON LABORATORIES, INC. |
| K031784 |
06/10/2003 |
ACON STREP A RAPID TEST DEVICE |
ACON LABORATORIES, INC. |
| K041743 |
06/28/2004 |
ACON TRI-FECT DRUG SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
| K041822 |
07/06/2004 |
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE |
ACON LABORATORIES, INC. |
| K012215 |
07/16/2001 |
QUIK-CHECK HOME PREGNANCY TEST |
ACON LABORATORIES, INC. |
| K012300 |
07/20/2001 |
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE |
ACON LABORATORIES, INC. |
| K022589 |
08/05/2002 |
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE |
ACON LABORATORIES, INC. |
| K042151 |
08/09/2004 |
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST |
ACON LABORATORIES, INC. |
| K012595 |
08/10/2001 |
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE |
ACON LABORATORIES, INC. |
| K032510 |
08/14/2003 |
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST |
ACON LABORATORIES, INC. |
| K012824 |
08/23/2001 |
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE |
ACON LABORATORIES, INC. |
| K032661 |
08/28/2003 |
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) |
ACON LABORATORIES, INC. |
| K032903 |
09/17/2003 |
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE |
ACON LABORATORIES, INC. |
| K033041 |
09/29/2003 |
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP |
ACON LABORATORIES, INC. |
| K033047 |
09/29/2003 |
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE |
ACON LABORATORIES, INC. |
| K013380 |
10/12/2001 |
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE |
ACON LABORATORIES, INC. |
| K033299 |
10/14/2003 |
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE |
ACON LABORATORIES, INC. |
| K023946 |
11/27/2002 |
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
| K043507 |
12/20/2004 |
ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE |
ACON LABORATORIES, INC. |
| K024350 |
12/30/2002 |
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE |
ACON LABORATORIES, INC. |
| K041685 |
06/22/2004 |
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
| K041946 |
07/19/2004 |
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE |
ACON LABORATORIES, INC. |
| K042272 |
08/23/2004 |
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) |
ACON LABORATORIES, INC. |
| K041165 |
05/04/2004 |
FSH MENOPAUSE PREDICTOR TEST |
ACON LABORATORIES, INC. |
| K012252 |
07/18/2001 |
QUIK-CHECK OVULATION PREDICTOR |
ACON LABORATORIES, INC. |
| K063295 |
11/01/2006 |
ACON UTI URINARY TRACT INFECTION TEST STRIPS |
ACON LABORATORIES, INC. |
| K063418 |
11/13/2006 |
ACON DIGITAL THERMOMETER PROBE COVERS |
ACON LABORATORIES, INC. |
| K993065 |
09/13/1999 |
ACON COMBO PREGNANCY |
ACON LABORATORIES, INC. |
| K070929 |
04/03/2007 |
ACON U120 URINE ANALYZER, MODEL U111-101 |
ACON LABORATORIES, INC. |
| K993203 |
09/24/1999 |
ACON ONE STEP PREGNANCY TEST STRIP (URINE) |
ACON LABORATORIES, INC. |
| K993317 |
10/04/1999 |
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) |
ACON LABORATORIES, INC. |
| K993483 |
10/14/1999 |
ACON ONE STEP HOME PREGNANCY TEST STRIP |
ACON LABORATORIES, INC. |
| K003557 |
11/17/2000 |
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) |
ACON LABORATORIES, INC. |
| K983090 |
09/03/1998 |
ACON MIDSTREAM PREGNANCY TEST |
ACON LABORATORIES, INC. |
| K120124 |
01/17/2012 |
FORESIGHT U120 URINE ANALYZER |
ACON LABORATORIES, INC. |
| K180196 |
01/24/2018 |
On Call Express Mobile Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K130284 |
02/05/2013 |
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
| K150330 |
02/10/2015 |
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) |
ACON Laboratories, Inc. |
| K180504 |
02/26/2018 |
Mission Lipid Panel Monitoring System |
ACON Laboratories, Inc. |
| K170587 |
02/28/2017 |
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis |
ACON Laboratories, Inc. |
| K191038 |
04/18/2019 |
On Call Express Voice Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K111221 |
05/02/2011 |
MISSION U500 URINE ANALYZER |
ACON LABORATORIES, INC. |
| K111371 |
05/16/2011 |
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
| K131469 |
05/21/2013 |
ACON ON CALL DIABETES MANAGEMENT SOFTWARE |
ACON LABORATORIES, INC. |
| K181527 |
06/11/2018 |
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K151595 |
06/12/2015 |
On Call Express Pro Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K132086 |
07/05/2013 |
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
| K122110 |
07/17/2012 |
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
| K192175 |
08/12/2019 |
On Call Express II Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K122553 |
08/21/2012 |
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM |
ACON LABORATORIES, INC. |
| K142391 |
08/27/2014 |
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) |
ACON LABORATORIES, INC. |
| K142543 |
09/10/2014 |
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control |
ACON LABORATORIES, INC. |
| K112653 |
09/12/2011 |
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS |
ACON LABORATORIES, INC. |
| K101371 |
05/17/2010 |
ON CALL PLUS DIABETES MONITORING SOFTWARE |
ACON LABORATORIES, INC. |
| K093143 |
10/05/2009 |
MISSION BREATH ALCOHOL DETECTOR |
ACON LABORATORIES, INC. |
| K103387 |
11/18/2010 |
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL |
ACON LABORATORIES, INC. |
| K093879 |
12/18/2009 |
MISSION SALIVA ALCOHOL TEST STRIP |
ACON LABORATORIES, INC. |
| K010841 |
03/21/2001 |
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE |
ACON LABORATORIES, INC. |
| K123010 |
09/27/2012 |
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
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