FDA 510(k) Applications for Medical Device:
System, Test, Human Chorionic Gonadotropin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983424 | ABBOTT LABORATORIES |
100/200 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K170317 | ABBOTT LABORATORIES |
DEPT. 09AA, BLDG AP8 | ABBOTT PARK | IL | 60064 |
| K230937 | Abbott Laboratories |
1915 Hurd Drive | Irving | TX | 75038 |
| K230790 | Abbott Laboratories |
1915 Hurd Drive | Irving | TX | 75038 |
| K133002 | ABBOTT POINT OF CARE INC. |
400 COLLEGE ROAD EAST | PRINCETON | NJ | 08540 |
| K031052 | ACCESS BIO INCORPORATE |
675 US HIGHWAY 1 | NORTH BRUNSWICK | NJ | 08902 |
| K022681 | AZOG, INC. |
1011 US HWY 22 | PHILLIPSBURG | NJ | 08865 |
| K022680 | AZOG, INC. |
1011 US HWY 22 | PHILLIPSBURG | NJ | 08865 |
| K961351 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K221990 | Beckman Coulter, Inc |
1000 Lake Hazeltine Drive | Chaska | MN | 55318 |
| K130020 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K961792 | BIOCIRCUITS CORP. |
1324 CHESAPEAKE TERR. | SUNNYVALE | CA | 94089 |
| K961487 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K063754 | DADE BEHRING, INC. |
P.O. BOX 6101 BLDG 500;M.S.514 | NEWARK | DE | 19714-6101 |
| K060548 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K003696 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K970387 | DADE CHEMISTRY SYSTEMS, INC. |
RT. 896, GLASCOW BLDG. 500 | GLASGOW | DE | 19702 |
| K033234 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K990222 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K994085 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K131037 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K163418 | Diazyme Laboratories |
12889 Gregg Court | Poway | CA | 92130 |
| K212221 | Diazyme Laboratories Inc. |
12889 Gregg Court | Poway | CA | 92064 |
| K955707 | EXCEL SCIENTIFIC, INC. |
23071 LA PALMA AVE. | YORBA LINDA | CA | 92887 |
| K013857 | GERMAINE LABORATORIES, INC. |
4139 GARDENDALE CENTER, | SAN ANTONIO | TX | 78229 |
| K974512 | GERMAINE LABORATORIES, INC. |
4203 GARDENDALE CENTER, #230 | SAN ANTONIO | TX | 78229 |
| K974368 | GERMAINE LABORATORIES, INC. |
4203 GARDENDALE CENTER, #230 | SAN ANTONIO | TX | 78229 |
| K973825 | GERMAINE LABORATORIES, INC. |
4203 GARDENDALE CENTER, #230 | SAN ANTONIO | TX | 78229 |
| K072500 | Guangzhou Wondfo Biotech Co., Ltd. |
8903 SPRUCE MILL DRIVE | YARDLEY | PA | 19067 |
| K991515 | INBIOS INTL., INC. |
562 1ST. AVE. SOUTH, SUITE 600 | SEATTLE | WA | 98104 |
| K970894 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14650-0882 |
| K991532 | METRIKA, INC. |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085-4022 |
| K000844 | MIZUHO USA, INC. |
6730 MESA RIDGE RD., SUITE D | SAN DIEGO | CA | 92121 |
| K042676 | NICHOLS INSTITUTE DIAGNOSTICS |
1311 CALLE BATIDO | SAN CLEMENTE | CA | 92673 |
| K080094 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
3131 WEST ROYAL LANE | IRVING | TX | 75063 |
| K063720 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K974425 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K203227 | ROCHE DIAGNOSTICS |
9115 Hague Road | Indianapolis | IN | 46250 |
| K003178 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K002148 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K192547 | Shenzhen New Industries Biomedical Engineering Co., Ltd |
No.16, Jinhui Road, Pingshan New District | Shenzhen | 518122 | |
| K192790 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Ave. | Tarrytown | NY | 10591 |
| K200210 | Siemens Healthcare Diagnostics, Inc. |
511 Benedict Ave. | Tarrytown | NY | 10591 |
| K013678 | VICTORCH MEDITEK, INC. |
7313 CARROLL RD., SUITE A-B | SAN DIEGO | CA | 92121 |
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