FDA 510(k) Applications for Medical Device:
Immunoassay Method, Troponin Subunit
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K974103 | ABBOTT LABORATORIES |
100/200 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K060875 | ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD | ABBOTT PARK | IL | 60064-3500 |
| K041811 | ABBOTT LABORATORIES |
DEPT. 9V6, BLDG. AP6C-3 | ABBOTT PARK | IL | 60064-6095 |
| K230994 | Abbott Laboratories Diagnostics Division |
100 Abbott Park Rd. | Abbott Park | IL | 60064 |
| K202525 | Abbott Laboratories Diagnostics Division |
Dept. 9AA, CP01-2 | Abbott Park | IL | 60064-6038 |
| K191595 | Abbott Laboratories Diagnostics Division |
Dept. 09AA, Bldg. AP8, 100 Abbott Park Road | Abbott Park | IL | 60064-6038 |
| K051925 | ACCESS BIO INCORPORATE |
2033 RT. 130 UNIT H | MONMOUTH JCT. | NJ | 08852 |
| K042227 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K010201 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K993309 | BAYER CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K973616 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K993353 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K053020 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K052503 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K121790 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K121214 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K172783 | Beckman Coulter, Inc. |
1000 Lake Hazeltine Drive MS R-540-C | Chaska | MN | 55318-1084 |
| K172787 | Beckman Coulter, Inc. |
Immunodiagnostic Development Center | Chaska | MN | 55318 |
| K021814 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K010429 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K974075 | BECKMAN INSTRUMENTS, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K955284 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K963934 | BIO-RAD LABORATORIES, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K041619 | BIOCHECK, INC. |
9418 LASAINE AVE. | NORTHRIDGE | CA | 91325 |
| K013062 | BIOCHECK, INC. |
9418 LASAINE AVE. | NORTHRIDGE | CA | 91325 |
| K030950 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K063243 | BIOMERIEUX, INC. |
595 ANGLUM DR. | HAZELWOOD | MO | 63042-2320 |
| K955868 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K964372 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K961500 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K984105 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K980528 | CHIRON DIAGNOSTICS CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052 |
| K010313 | DADE BEHRING, INC. |
P.O. BOX 6101, BUILDING 500 | NEWARK | DE | 19714 |
| K053577 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K063756 | DADE BEHRING, INC. |
BLDG. 500 MAIL BOX 514 | NEWARK | DE | 19714-6101 |
| K991177 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K984093 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K033487 | DADE BEHRING, INC. |
P.O. BOX 6101 BUILDING 500 | NEWARK, | DE | 19714 |
| K981098 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K973650 | DADE CHEMISTRY SYSTEMS, INC. |
RT. 896, GLASCOW BLDG. 500 | GLASGOW | DE | 19702 |
| K964862 | DADE INTL., INC. |
2173 NW 99TH AVE. | MIAMI | FL | 33172 |
| K983972 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K991795 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K974839 | FIRST MEDICAL, INC. |
530 LOGUE AVE. | MOUNTAIN VIEW | CA | 94043 |
| K010562 | FIRST MEDICAL, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K014024 | FIRST MEDICAL, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K070640 | FISHER DIAGNOSTICS |
8365 VALLEY PIKE, PO BX 307 | MIDDLETOWN | VA | 22645 |
| K041192 | FISHER DIAGNOSTICS |
8365 VALLEY PIKE, PO BX 307 | MIDDLETOWN | VA | 22645 |
| K031739 | I-STAT CORPORATION |
104 WINDSOR CENTER DR. | EAST WINDSOR | NJ | 08520 |
| K100130 | MITSUBISHI CHEMICAL MEDIENCE CO |
PO BOX 103 | BALDWIN | MD | 21013 |
| K050975 | NANO-DITECH CO. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K102441 | NANO-DITECH CORPORATION |
7 CLARKE DRIVE | CRANBURY | NJ | 08512 |
| K102131 | NANO-DITECH CORPORATION |
7 CLARKE DRIVE | CRANBURY | NJ | 08512 |
| K024193 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K020662 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K062838 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K992366 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K031031 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K981882 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K963513 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K022946 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K974818 | RADIOMETER AMERICA, INC. |
810 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K033745 | RESPONSE BIOMEDICAL CORP. |
8081 LOUGHEED HWY. | BURNABY, BRITISH COLUMBIA | V5A 1W9 | |
| K082699 | Roche Diagnostics |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K201441 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K162895 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K051752 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K040733 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K000784 | ROCHE DIAGNOSTICS CORP. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K081643 | SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K171274 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K171566 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K190675 | Siemens Healthcare Diagnostics, Inc. |
500 GBC Drive | Newark | DE | 19714 |
| K182225 | Siemens Healthcare Diagnostics, Inc. |
500 GBC Drive | Newark | DE | 19714 |
| K992127 | SPECTRAL DIAGNOSTICS, INC. |
5550 N.W. 102 PLACE | MIAMI | FL | 33178 |
| K030057 | SPECTRAL DIAGNOSTICS, INC. |
135-2 THE WEST MALL | TORONTO, ONTARIO | M9C1C2 | |
| K020950 | SPECTRAL DIAGNOSTICS, INC. |
135-2 THE WEST MALL | TORONTO, ONTARIO | M9C1C2 | |
| K014105 | SPECTRAL DIAGNOSTICS, INC. |
135-2 THE WEST MALL | TORONTO, ONTARIO | M9C1C2 | |
| K972094 | TEXAS IMMUNOLOGY, INC. |
5400 SPUR 248 | TYLER | TX | 75707 |
| K012820 | TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., | SAN FRANCISCO | CA | 94080 |
| K984359 | TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., | SAN FRANCISCO | CA | 94080 |
| K050644 | VANCOUVER BIOTECH LTD. |
9121 SHAUGHNESSY ST. | VANCOUVER | V6P 6R9 | |
| K023505 | VANCOUVER BIOTECH LTD. |
9418 LASAINE AVE. | NORTHRIDGE | CA | 91325 |
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