FDA 510(k) Applications for Medical Device:
Test, Cystatin C
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K063351 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K041878 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K003503 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K041627 | DAKO A/S |
42 PRODUKTIONSVEJ | GLOSTRUP | DK-2600 | |
| K093680 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K111664 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K072270 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K071388 | GENTIAN AS |
9915 CAM. CHIRIMOLLA | SAN DIEGO | CA | 92131 |
| K081875 | GENTIAN AS |
9915 CAM. CHIRIMOLLA | SAN DIEGO | CA | 92131 |
| K080662 | GENZYME CORPORATION |
31 NEW YORK AVENUE | FRAMINGHAM | MA | 01701-9322 |
| K093137 | KAMIYA BIOMEDICAL CO. |
12779 GATEWAY DR. | SEATTLE | WA | 98168 |
| K141143 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K080811 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K161817 | Roche Diagnostics Operations (RDO) |
9115 Hague Road | Indianapolis | IN | 46250 |
| K083906 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K171072 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring-Str. 76 | Marburg | 35041 | |
| K181082 | Siemens Healthcare Diagnostics, Inc. |
500 GBC Drive | Newark | NJ | 19714 |
| K072166 | THE BINDING SITE |
2425 WEST OLYMPIC BOULEVARD | SANTA MONICA | CA | 90404 |
| K080384 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K063647 | THERMO ELECTRON OY |
RATASTIE 2 | VANTAA | FIN-01621 | |
| K093960 | Tosoh BioScience, Inc. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
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