FDA 510(k) Applications Submitted by FRAN WHITE

FDA 510(k) Number Submission Date Device Name Applicant
K080012 01/03/2008 PLATELIA LYME IGG ASSAY BIO-RAD
K010244 01/25/2001 SURE CHECK OVULATION PREDICTOR Chembio Diagnostic Systems, Inc.
K140198 01/27/2014 IMDX HSV-1/2 FOR ABBOTT M2000 Intelligent Medical Devices, Inc.
K000367 02/04/2000 SECURMIX EUROSPITAL
K070361 02/07/2007 MRSASELECT BIO-RAD
K070577 02/28/2007 ON THE GO SHARPS MEDPORT, INC.
K100589 03/02/2010 MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS BIO-RAD
K030658 03/03/2003 STANDARD THERMOMETER GLOBAL TREASURE INDUSTRIES LTD.
K030673 03/04/2003 FLEXIBLE TIP THERMOMETER, MODEL 011206 GLOBAL TREASURE INDUSTRIES LTD.
K030912 03/24/2003 THYRO TEST THRYOTEC
K981084 03/25/1998 URISCREEN DIATECH DIAGNOSTICS,INC.
K130831 03/26/2013 MALDI BIOTYPER CA (MBT-CA) SYSTEM BRUKER DALTONICS, INC
K021006 03/28/2002 STARTOX DRUG OF ABUSE SCREENING TEST STARPLEX SCIENTIFIC, INC.
K031271 04/22/2003 ONE-STEP PREGNANCY TEST AMERISOURCE PHARMACAL, INC.
K081212 04/29/2008 MRSASELECT - EXTENDED INCUBATION BIO-RAD
K041165 05/04/2004 FSH MENOPAUSE PREDICTOR TEST ACON LABORATORIES, INC.
K041202 05/07/2004 HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST W.H.P.M., INC.
K041273 05/12/2004 ONE-STEP PREGNANCY TEST W.H.P.M., INC.
K081362 05/15/2008 PLATELIA LYME IGM BIO-RAD
K011550 05/18/2001 HCG STAT PAK ULTRA-FAST Chembio Diagnostic Systems, Inc.
K011551 05/18/2001 SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc.
K131584 05/31/2013 IMDX FLU A/B AND RSV FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC
K962296 06/12/1996 STREPTOLEX-STAT UNIPATH LTD.
K012159 06/22/2001 RAPID DRUG SCREEN AMERICAN BIO MEDICA CORP.
K041696 06/22/2004 RAPID READER AMERICAN BIO MEDICA CORP.
K051841 07/07/2005 WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST W.H.P.M., INC.
K111951 07/08/2011 ISOAMP HSV ASSAY BIOHELIX CORPORATION
K092116 07/14/2009 EASYCELL CELL LOCATOR MEDICA CORP.
K962721 07/15/1996 EVIDENCE PREGNANCY TEST SALIVA DIAGNOSTIC SYSTEMS
K012252 07/18/2001 QUIK-CHECK OVULATION PREDICTOR ACON LABORATORIES, INC.
K132235 07/18/2013 IMDX C.DIFFICILE FOR ABBOTT M2000 Intelligent Medical Devices, Inc.
K012284 07/20/2001 WH ACCU TEST PREGNANCY TEST W.H.P.M., INC.
K022386 07/22/2002 POCKETCHEM UA AUTION STICKS 10TA ARKRAY, INC.
K022388 07/23/2002 STARTOX DRUG OF ABUSE SCREENING TEST (4) STARPLEX SCIENTIFIC, INC.
K122187 07/24/2012 VRESELECT CULTURE MEDIUM BIO-RAD
K142156 08/06/2014 SEEGENE ANYPLEX II HSV-1/2 ASSAY SEEGENE
K972960 08/11/1997 HEALTH CHECK URI-TEST PROTEIN IN URINE TCPI, INC.
K052197 08/12/2005 FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST W.H.P.M., INC.
K072249 08/13/2007 EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT MEDICA CORP.
K032575 08/20/2003 FIRST SIGN DRUG OF ABUSE SCREENING TEST W.H.P.M., INC.
K963326 08/23/1996 BREATHE FIT CAMBRIDGE ASSOC.
K992915 08/30/1999 ONE-STEP DOUBLE-CHEK PREGNANCY TEST BIOMEDICAL PRODUCTS CORP.
K023069 09/16/2002 TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER MEDPORT, INC.
K954685 10/11/1995 URITEST - NITRITE IN URINE TEST TCPI, INC.
K023538 10/21/2002 TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER MEDPORT, INC.
K954968 10/27/1995 HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST TCPI, INC.
K043033 11/03/2004 GLOBAL TREASURES FLUID FILLED TEETHER GLOBAL TREASURE INDUSTRIES LTD.
K063340 11/06/2006 SAF-T-SYRINGE- 0.5 AND 1ML/CC SAFETY MEDICAL INTERNATIONAL, INCORPORATED
K964487 11/07/1996 IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964491 11/07/1996 NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964489 11/08/1996 CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964490 11/08/1996 AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964493 11/08/1996 OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964495 11/08/1996 CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964496 11/08/1996 CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC UNIPATH LTD.
K964501 11/08/1996 SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964512 11/08/1996 CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964492 11/08/1996 CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K053138 11/09/2005 MYSET PREGNANCY TEST ANI BIOTECH OY
K053359 12/02/2005 RAPIDTOX AMERICAN BIO MEDICA CORP.
K123753 12/06/2012 IMDX VANR FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC
K183462 12/14/2018 Applied Biosystems Bacillus anthracis Detection Kit MRIGlobal
K103684 12/17/2010 VRESELECT CULTURE MEDIUM BIO-RAD
K063868 12/29/2006 MASSTRAK IMMUNOSUPPRESSANTS KIT WATERS CORPORATION


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