FDA 510(k) Applications Submitted by EDWARD TUNG, PH.D.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
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. |
K020313 |
01/30/2002 |
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE |
ACON LABORATORIES CO. |
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. |
K061718 |
06/19/2006 |
INNOVACON SPECTRUM II TEST CARD |
INNOVACON, 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. |
K062361 |
08/14/2006 |
INNOVACON HCG UKTRA TEST DEVICE |
INNOVACON, 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. |
K122809 |
09/13/2012 |
ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP |
ADVIN BIOTECH |
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. |
K023766 |
11/12/2002 |
ACON STREP A TWIST TEST DEVICE |
ACON LABORATORIES CO. |
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. |
K063673 |
12/11/2006 |
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE |
INNOVACON, 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. |
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