FDA 510(k) Applications for Medical Device:
Counter, Differential Cell

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K961439 ABBOTT DIAGNOSTICS 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K980614 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K972354 ABBOTT LABORATORIES 100 ABBOTT PARK RD.
ABBOTT PARK IL 60064-3500
K971152 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K981342 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K220031 Abbott Laboratories 4551 Great America Pkwy
Santa Clara CA 95054
K955673 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K955715 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K991142 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K030513 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K012934 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K991605 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K010953 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K190294 Abbott Laboratories 4551 Great America Pkwy
Santa Clara CA 95054
K110381 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K081495 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K061667 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K051215 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K992444 ABBOTT LABORATORIES 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K002646 ABX DIAGNOSTICS 34 BUNSEN DR.
IRVINE CA 92618-4210
K991839 ABX DIAGNOSTICS 7777 CENTER AVE.
HUNTINGTON BEACH CA 92647
K992511 ABX DIAGNOSTICS 34 BUNSEN DR.
IRVINE CA 92618-4210
K003677 ABX DIAGNOSTICS 34 BUNSEN DR.
IRVINE CA 92618-4210
K030799 ABX DIAGNOSTICS PARC EUROMEDECINE
MONTPELLIER CEDEX 34184
K030144 ABX DIAGNOSTICS PARC EUROMEDECINE
MONPELLIER 34184
K022200 ABX DIAGNOSTICS PARC EUROMEDECINE
MONPELLIER 34184
K024002 ABX DIAGNOSTICS PARC EUROMEDECINE
MONPELLIER 34184
K990311 ABX DIAGNOSTICS 7777 CENTER AVE.
HUNTINGTON BEACH CA 92647
K962633 ABX, INC. RUE DU CADUCEE-BP7290
MONTPELLIER CEDEX 4 34184
K200828 Athelas Inc. 67 E Evelyn Ave.
Mountain View CA 94041
K181288 Athelas Inc. 10209 Danube Dr.
Cupertino CA 95014
K003796 BAYER CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K982802 BAYER CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K954594 BAYER CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K022668 BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K012904 BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K032524 BAYER HEALTHCARE, LLC 511 BENEDICT AVE.
TARRYTOWN NY 10591
K042251 BAYER HEALTHCARE, LLC 511 BENEDICT AVE.
TARRYTOWN NY 10591
K992849 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE
SPARKS MD 21152-0999
K062087 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K041074 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K081213 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K060375 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K090967 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K071141 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K071143 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K000897 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K000611 BD Biosciences 2350 QUME DR.
SAN JOSE CA 95131-1807
K182886 Beckman Coulter 11800 SW 147th Ave
Miami FL 33196-2500
K181475 Beckman Coulter 11800 SW 147th Ave
Miami FL 33196-2500
K193124 Beckman Coulter 11800 SW 147th Ave
Miami FL 33196-2500
K100489 BECKMAN COULTER CELLULAR 11800 SW 147 AVENUE
MIAMI FL 33196-2500
K042173 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K032013 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K030291 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K010765 BECKMAN COULTER, INC. 11800 S.W. 14TH AVE.
MIAMI FL 33116-9015
K032000 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K030606 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K032342 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K050057 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K011342 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K061574 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K061616 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K030408 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K071681 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K043215 BECKMAN COULTER, INC. 11800 S.W. 147 AVE.
MIAMI FL 33196-2500
K081526 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K051122 BECKMAN COULTER, INC. 7330 CARROLL RD.
SAN DIEGO CA 92121
K042724 BECKMAN COULTER, INC. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K052905 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K022161 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K030828 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K081930 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K120771 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196-2500
K140911 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196
K162414 BECKMAN COULTER, INC. 11800 SW 147TH AVE.
MIAMI FL 33196
K102064 BECTON DICKINSON & CO. 2350 QUME DRIVE
SAN JOSE CA 95131-1807
K955504 BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE
SPARKS MD 21152-0999
K960827 BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE
SPARKS MD 21152-0999
K040026 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K040725 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K973483 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K963963 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K980858 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K974360 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K971205 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K970742 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K971110 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K950342 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K946055 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K965053 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K970326 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K970836 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR.
SAN JOSE CA 95131-1807
K961623 BECTON DICKINSON MONOCLONAL CENTER 2350 Qume Dr.
San Jose CA 95131
K960072 BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 1151 HOPE ST.
STAMFORD CT 06907
K032214 BOULE MEDICAL AB 1660 N.W. 65TH AVE SUITE 2
PLANTATION FL 33313
K083420 BOULE MEDICAL AB 1800 N.W. 65TH AVE
PLANTATION FL 33313
K965232 CALTAG LABORATORIES, INC. 605 DILWORTH RD.
DOWNINGTOWN PA 19335
K963954 CALTAG LABORATORIES, INC. 605 DILWORTH RD.
DOWNINGTOWN PA 19335
K964856 CALTAG LABORATORIES, INC. 605 DILWORTH RD.
DOWNINGTOWN PA 19335
K981568 CDC TECHNOLOGIES, INC. 1250 24TH STREET, N.W. 7TH FL
WASHINGTON DC 20037
K983562 CDC TECHNOLOGIES, INC. 1250 24TH STREET, N.W. 7TH FL
WASHINGTON DC 20037
K942525 CEA AMERICA CORP. 5300 MEMORIAL DR. #310
HOUSTON TX 77007
K050758 CHEMPAQ A/S 555 THIRTEENTH STREET NW
WASHINGTON DC 20004-1109
K090013 CHEMPAQ A/S HIRSEMARKEN 1B
FARUM DK-3520
K990352 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K973634 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K964988 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K993356 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K961278 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K982172 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K982167 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K962768 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K982166 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K962305 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K964618 COULTER CORP. P.O. BOX 169015
MAIMI FL 33116-9015
K954688 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K990327 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K963263 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K990172 COULTER CORP. 11800 S.W. 147TH AVE.
MIAMI FL 33196-2500
K980635 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K991402 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K945212 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K961435 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K955909 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K961701 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K960531 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K960887 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K964974 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K991454 DAKO CORP. 6392 VIA REAL
CARPINTERIA CA 93013
K060423 DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL
CARPINTERIA CA 93013
K111534 DIATRON US INC 14026 W. 107TH STREET
LENEXA KS 66215-2005
K112755 DIATRON US INC 14026 W. 107TH STREET
LENEXA KS 66215-2005
K071562 DREW SCIENTIFIC, INC. 4230 SHILLING WAY
DALLAS TX 75237
K053497 GUAVA TECHNOLOGIES, INC. 25801 INDUSTRIAL BLVD.
HAYWARD CA 94545
K053308 HORIBA ABX PARC EUROMEDECINE
MONTPELLIER, HERAULT 34184
K050719 HORIBA ABX PARC EUROMEDECINE
MONTPELLIER, HERAULT 34184
K141161 HORIBA ABX SAS PARC EUROMEDECINE
MONTPELLIER 34184
K170353 HORIBA ABX SAS Parc Euromedecine
Montpellier Cedex 4 34184
K151133 HORIBA ABX SAS PARC EUROMEDECINE
MONTPELLIER Cedex 4 34184
K153538 Immudex Aps Fruebjergvej 3
Copenhagen 2100
K030263 IMMUNICON CORP. 3401 MASONS MILL RD. STE 100
HUNTINGDON VALLEY PA 19006-3574
K953116 INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE.
CHATSWORTH CA 91311
K022528 IQ CORP. 11511 SW 127TH ST.
MIAMI FL 33176
K050421 MELET SCHLOESING LABORATORIES USA 2030 GILLEPSIE WAY, SUITE 104
EL CAJON CA 92020
K050436 MELET SCHLOESING LABORATORIES USA 7703 CONVOY CT
SAN DIEGO CA 92111
K090810 MICROGENICS CORP. 46360 FREMONT BLVD
FREMONT CA 94538
K143348 MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Mindray Building, Keji 12th Road South
Shenzhen 518057
K160429 MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD
NANSHAN 518057
K991539 MWI, INC. 4230 SHILLING WAY
DALLAS TX 75237
K935720 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K954570 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K951100 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K950568 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K950625 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K951632 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K950482 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K964754 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K951459 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869-0606
K180020 PixCell Medical Technologies, Ltd. 6 Hayezira St.
Yoknaem Ilit 2069202
K222148 PixCell Medical Technologies, Ltd. 6 Hayezira St.
Yoknaem Ilit 2069202
K041882 POINTCARE TECHNOLOGIES INC. 49 PLAIN STREET
NORTH ATTLEBORO MA 02760
K072869 POINTCARE TECHNOLOGIES INC. 181 CEDAR HILL ST.
MARLBOROUGH MA 01752
K961610 R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E.
MINNEAPOLIS MN 55413
K982231 R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E.
MINNEAPOLIS MN 55413
K082091 REAMETRIX INC. 1585 INDUSTRIAL RD.
SAN CARLOS CA 94070
K171655 Roche Diagnostics Hematology, Inc. 69 Milk Street, Suite 120
Westborough MA 01581
K211840 S.D. Sight Diagnostics Ltd. 23 Menachem Begin Rd.
Tel Aviv 6618356
K960427 SEQUOIA TURNER CORP. 5440 PATRICK HENRY DR.
SANTA CLARA CA 95054
K953598 SERONO DIAGNOSTICS, INC. 555 13TH STREET, N.W.
WASHINGTON DC 20004-5910
K063407 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200
GREAT NECK NY 11021
K093394 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200
GREAT NECK NY 11021
K102644 SIEMENS HEALTHCARE DIAGNOSTICS 511 benedict Avenue
Tarrytown NY 10591
K090346 SIEMENS HEALTHCARE DIAGNOSTICS 511 benedict Avenue
Tarrytown NY 10591
K162977 SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE
TARRYTOWN NY 10591
K190898 Sight Diagnostics Ltd. Derech Menachem Begin 23
Tel Aviv
K032039 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K051199 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K050589 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K060656 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K040073 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K061150 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K051459 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K081610 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K091313 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K071967 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K141681 SYSMEX AMERICA, INC. 577 Aptakisic Rd
Lincolnshire IL 60069
K160538 SYSMEX AMERICA, INC. 577 APTAKISIC ROAD
Lincolnshire IL 60069
K182389 Sysmex America, Inc. 577 Aptakisic Road.
Lincolnshire IL 60069
K112605 SYSMEX AMERICA, INC. 577 Aptakisic Rd
Lincolnshire IL 60069
K081890 SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY
MUNDELEIN IL 60060
K210346 Sysmex America, INC. 577 Aptakisic Road
Lincolnshire IL 60069-4325
K172604 Sysmex America, Inc. 577 Aptakisic Road
Lincolnshire IL 60069
K143577 SYSMEX AMERICA, INC. 577 Aptakisic Road
Lincolnshire IL 60069
K971736 SYSMEX CORP. GILMER RD.
LONG GROVE IL 60047-9596
K992875 SYSMEX CORP. ONE WILDLIFE WAY
LONG GROVE IL 60047-9596
K020496 SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY
LONG GROVE IL 60047-9596
K021241 SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY
LONG GROVE IL 60047-9596
K953643 TEXAS INTL. LABORATORIES, INC. 5 RAIN HOLLOW
HOUSTON TX 77024




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