FDA 510(k) Applications for Medical Device:
Calibrator, Multi-Analyte Mixture
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K123372 | ABBOTT LABORATORIES |
1921 HURD DR. | IRVING | TX | 75038 |
| K981706 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K103403 | ABBOTT LABORATORIES |
1921 HURD DRIVE | IRVING | TX | 75038-4396 |
| K001484 | ALKO DIAGNOSTIC CORP. |
333 FISKE ST. | HOLLISTON | MA | 01746-2048 |
| K982501 | ALKO DIAGNOSTIC CORP. |
333 FISKE ST. | HOLLISTON | MA | 01746 |
| K960085 | ALKO DIAGNOSTIC CORP. |
333 FISKE ST. | HOLLISTON | MA | 01746 |
| K970921 | ALKO DIAGNOSTIC CORP. |
333 FISKE ST. | HOLLISTON | MA | 01746 |
| K033380 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K030804 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K033791 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K031682 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K051619 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K030169 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K031683 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K141388 | BECKMAN COULTER IRELAND INC |
250 S. KRAEMER BLVD. E1.SE.01 | BREA | CA | 92821 |
| K032287 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K110251 | BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD | BREA | CA | 92821 |
| K984014 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K973932 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821-6208 |
| K973928 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821-6208 |
| K971333 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K971283 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K962406 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K962410 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K964062 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K964527 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K974825 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K962269 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K961659 | BOEHRINGER MANNHEIM CORP. |
BOEHRINGER MANNHEIM CO. | COLUMBUS | OH | |
| K964829 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K984425 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K983469 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K962629 | CASCO STANDARDS |
P.O BOX 970 | YARMOUTH | ME | 04096 |
| K981436 | CASCO STANDARDS |
500 RIVERSIDE INDUSTRIAL PARK | PORTLAND | ME | 04103 |
| K030074 | CLINIQA CORPORATION |
1432 SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K033910 | CLINIQA CORPORATION |
1432 SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K011035 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K061838 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K061703 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K062334 | DADE BEHRING, INC. |
P.O. BOX BOX 6101, M/S 514 | NEWARK | DE | 19714-6101 |
| K061923 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K063508 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K062055 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K072435 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K062035 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K062122 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K061218 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K062034 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K061390 | DADE BEHRING, INC. |
500 GBC DR, MAILSTOP 514 | NEWARK | DE | 19714-6101 |
| K061750 | DADE BEHRING, INC. |
500 GBC DR, MAILSTOP 514 | NEWARK | DE | 19714-6101 |
| K991181 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K012470 | DADE BEHRING, INC. |
GLASGOW SITE | NEWARK | DE | 19714-6101 |
| K041870 | DADE BEHRING, INC. |
514 GBC DR. | NEWARK | DE | 19702 |
| K002804 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K960103 | DADE INTL., INC. |
9750 N.W. 25TH ST. | MIAMI | FL | 33172 |
| K993098 | DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST | ARLINGTON | TX | 76011 |
| K013178 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K041926 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, PE | C1E 2A6 | |
| K042243 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, PRINCE EDWARD | C1E 2A6 | |
| K092113 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K033061 | DIAMOND DIAGNOSTICS, INC. |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K030621 | ELAN DIAGNOSTICS |
1075 W. LAMBERT RD., SUITE D | BREA | CA | 92821 |
| K992845 | ELAN HOLDINGS, INC. |
231 NORTH PUENTE ST. | BREA | CA | 92821 |
| K151552 | ELITechGroup |
ZONE INDUSTRIELLE | Sees | 61500 | |
| K112029 | ELITECHGROUP |
21720 23RD DR SE | BOTHELL | WA | 98021 |
| K130765 | ELITECHGROUP |
21720 23RD DR SE | BOTHELL | WA | 98021 |
| K013397 | FISHER DIAGNOSTICS |
8365 VALLEY PIKE | MIDDLETOWN | VA | 22645-0307 |
| K090283 | GENCHEM, INC. |
510 WEST CENTRAL AVE., SUITE D | BREA | CA | 92821 |
| K022767 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K012250 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K071779 | HORIBA ABX |
PARC EUROMEDECINE | MONTPELLIER | 34184 | |
| K041905 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K993606 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K991166 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K993853 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K080404 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K032665 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K043460 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K981305 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K992086 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K161140 | ORTHO-CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DRIVE | ROCHESTER | NY | 14626-5101 |
| K060940 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K071801 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K023876 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K012509 | PHOENIX DIAGNOSTICS, INC. |
8 TECH CIRCLE | NATICK | MA | 01760 |
| K012987 | PHOENIX DIAGNOSTICS, INC. |
8 TECH CIRCLE | NATICK | MA | 01760 |
| K020129 | PHOENIX DIAGNOSTICS, INC. |
8 TECH CIRCLE | NATICK | MA | 01760 |
| K023268 | PHOENIX DIAGNOSTICS, INC. |
8 TECH CIRCLE | NATICK | MA | 01760 |
| K070207 | POINTE SCIENTIFIC, INC. |
5449 RESEARCH DRIVE | CANTON | MI | 48188 |
| K982767 | RAICHEM |
8225 MERCURY COURT | SAN DIEGO | CA | 92129 |
| K955489 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K023158 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K053153 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K061056 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K031608 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K011658 | ROCHDIAG |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K133330 | Roche Diagnostics |
9115 SOUTH HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K103171 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K050026 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K101456 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K031880 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K011226 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K990460 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K080607 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-3831 |
| K062319 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD | INDIANAPOLIS | IN | 46250-0457 |
| K040245 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K040264 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K033873 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K000576 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K033501 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K081533 | SENTINEL CH. SpA |
Via Robert Koch, 2 | Milano | 20152 | |
| K070971 | SENTINEL CH. SRL |
Via Robert Koch, 2 | Milano | 20152 | |
| K051452 | SENTINEL CH. SRL |
5 VIA PRINCIPE EUGENIO | MILANO | 20155 | |
| K051457 | SENTINEL CH. SRL |
5 VIA PRINCIPE EUGENIO | MILANO | 20155 | |
| K093732 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K123321 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K100778 | SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K140790 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE M/S 514 | NEWARK | DE | 19714 |
| K083579 | SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K093645 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K101460 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19714-6101 |
| K103612 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
500 GBC DRIVE | NEWARK | DE | 19714-6101 |
| K081103 | Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K122398 | Siemens Healthcare Diagnostics Inc. |
2 EDGEWATER DRIVE | NORWOOD | MA | 02062 |
| K153365 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K103701 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE | TARRYTOWN | NY | 10591 |
| K072204 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K963533 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST.LOUIS | MO | 63103 |
| K963543 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K010652 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K032936 | STANBIO LABORATORY |
1261 NORTH MAIN ST. | BOERNE | TX | 78006 |
| K010030 | SYNERGENT BIOCHEM INC.-CLINICAL CONTROLS DIV. |
12038 CENTRAILIA AVE. | HAWAIIAN GARDENS | CA | 90716 |
| K981795 | THERMO BIOANALYSIS CORP. |
333 FISKE ST. | HOLLISTON | MA | 01746 |
| K022108 | THERMO DMA, INC. |
845 AVE. G EAST | ARLINGTON | TX | 76011 |
| K073612 | THERMO FISHER SCIENTIFIC OY |
2 RATASTIE | VANTAA | FIN-01621 | |
| K023792 | THERMO ORION |
500 CUMMINGS CENTER | BEVERLY | MA | 01915-6199 |
| K972333 | VERICHEM LABORATORIES, INC. |
90 NARRAGANSETT AVE. | PROVIDENCE | RI | 02907 |
| K973345 | VERICHEM LABORATORIES, INC. |
90 NARRAGANSETT AVE. | PROVIDENCE | RI | 02907 |
| K974290 | VERICHEM LABORATORIES, INC. |
90 NARRAGANSETT AVE. | PROVIDENCE | RI | 02907 |
| K112834 | VERICHEM LABORATORIES, INC. |
90 NARRAGANSETT AVE. | PROVIDENCE | RI | 02907 |
| K110394 | VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
189-199 BROWNS RD | NOBLE PARK, VICTORIA | 3174 | |
| K042549 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K042551 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K042550 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K024305 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
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