FDA 510(k) Applications for Medical Device:
Radioimmunoassay, Parathyroid Hormone
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K232791 | Beckman Coulter Inc |
1000 Lake Hazeltine Drive | Chaska | MN | 55318 |
| K061190 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K063232 | BIOKIT S.A. |
CAN MALE LLISSA D'AMUNT | BARCELONA | 08186 | |
| K022603 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K013566 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K011505 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K992105 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K053533 | DIAGNOSTIC PRODUCTS CORPORATION |
5210 PACIFIC CONCOURSE DR. | LOS ANGELES | CA | 90045-6900 |
| K973514 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. | WEBSTER | TX | 77598 |
| K020945 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. | WEBSTER | TX | 77598 |
| K150879 | DiaSorin Inc. |
1951 Northwestern Avenue | Stillwater | MN | 55082-1482 |
| K033426 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082 |
| K132515 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K190702 | Fujirebio Diagnostics, Inc. |
201 Great Valley Pkwy | Malvern | PA | 19355 |
| K000471 | FUTURE DIAGNOSTICS B.V. |
4079 MT. BARNARD | SAN DIEGO | CA | 92111 |
| K161158 | IMMUNODIAGNOSTIC SYSTEMS LTD |
10 DIDCOT WAY | BOLDON | Ne35 9pd | |
| K103325 | IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, | BOLDON, TYNE & WEAR | NE35 9PD | |
| K962033 | NICHOLS INSTITUTE DIAGNOSTICS |
33608 ORTEGA HIGHWAY | SAN JUAN CAPISTRANO | CA | 92690-6130 |
| K033302 | NICHOLS INSTITUTE DIAGNOSTICS |
1311 CALLE BATIDO | SAN CLEMENTE | CA | 92673 |
| K033727 | NICHOLS INSTITUTE DIAGNOSTICS |
1311 CALLE BATIDO | SAN CLEMENTE | CA | 92673 |
| K013992 | NICHOLS INSTITUTE DIAGNOSTICS |
33051 CALLE AVIADOR | SAN JUAN CAPISTRANO | CA | 92675 |
| K962598 | NICHOLS INSTITUTE DIAGNOSTICS |
33608 ORTEGA HIGHWAY | SAN JUAN CAPISTRANO | CA | 92690-6130 |
| K040813 | NICHOLS INSTITUTE DIAGNOSTICS |
1311 CALLE BATIDO | SAN CLEMENTE | CA | 92673 |
| K022472 | NICHOLS INSTITUTE DIAGNOSTICS |
1311 CALLE BATIDO | SAN CLEMENTE | CA | 92673 |
| K221197 | Ortho Clinical Diagnostics |
Felindre Meadows | Bridgend | CF24 1QR | |
| K101921 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DRIVE | ROCHESTER | NY | 14626-0551 |
| K231927 | Roche Diagnostics |
9115 Hague Rd. | Indianapolis | IN | 46250 |
| K992680 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K070391 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K070709 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K974306 | SANGUI BIOTECH, INC. |
1508 BROOKHOLLOW DR., #354 | SANTA ANA | CA | 92705 |
| K031534 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K060420 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K060348 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K051150 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K051888 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K004038 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K051141 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K051810 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K001411 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K970483 | SEALITE SCIENCES, INC. |
3000 NORTHWOODS PKWY., #200 | NORCROSS | GA | 30071 |
| K121981 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K133601 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K163658 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K063605 | Tosoh BioScience, Inc. |
3600 GANTZ ROAD | GROVE CITY | OH | 43123 |
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