FDA 510(k) Applications for Medical Device:
System, Test, C-Reactive Protein
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K091052 | ABAXIS, INC. |
3240 WHIPPLE RD. | UNION CITY | CA | 94587 |
| K030899 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K991372 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K083040 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K012337 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K021572 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K040030 | BIOCHECK, INC. |
9418 LASAINE AVE. | NORTHRIDGE | CA | 91325 |
| K062981 | BODITECH DIAGNOSTICS, INC. |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301 |
| K011855 | CARTER-WALLACE, INC. |
P.O. BOX 1001 | CRANBURY | NJ | 08512 |
| K061825 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K003419 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K990825 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K011958 | DENKA SEIKEN'S |
3-4-2 NIHONBASHI | TOKYO | 103-0025 | |
| K003372 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K021757 | GOOD BIOTECH CORP. |
38, 34TH RD. | TAICHUNG | 407 | |
| K020603 | GOOD BIOTECH CORP. |
38, 34TH RD. | TAICHUNG | 407 | |
| K021882 | GOOD BIOTECH CORP. |
38, 34TH RD. | TAICHUNG CITY | ||
| K050713 | GOOD BIOTECH CORP. |
38, 34TH RD. | TAICHUNG | 407 | |
| K113809 | HITACHI CHEMICAL DIAGNOSTICS, INC. |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K022690 | HORIBA LTD. |
34 BUNSEN DR. | IRVINE | CA | 92618 |
| K171498 | Meso Scale Diagnostics, LLC |
1601 Research Boulevard | Rockville | MD | 20850 |
| K083412 | MITSUBISHI KAGAKU IATRON |
701 FIFTH AVENUE | SEATTLE | WA | 98104 |
| K954537 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K002918 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K083444 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0416 |
| K003400 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K073277 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K032336 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K192072 | Roche Diagnostics Operations (RDO) |
9115 Hague Rd | Indianapolis | IN | 46250 |
| K221119 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K072658 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K974429 | STANBIO LABORATORY |
2930 EAST HOUSTON ST. | SAN ANTONIO | TX | 78202 |
| K161982 | THE BINDING SITE GROUP |
8 CALTHORPE ROAD, EDGBASTON | BIRMINGHAM | B15 1QT | |
| K180099 | The Binding Site Group Ltd |
8 Calthorpe Road, Edgbaston | Birmingham | B15 1QT | |
| K172868 | The Binding Site Group Ltd. |
8 Calthorpe Road, Edgbaston | Birmingham | B15 1QT | |
| K003342 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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