FDA 510(k) Applications for Medical Device:
Colorimetric Method, Cpk Or Isoenzymes
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K961412 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K974421 | BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR. | PLEASANTON | CA | 94588-2722 |
| K970343 | DADE CHEMISTRY SYSTEMS, INC. |
RT. 896, GLASCOW BLDG. 500 | GLASGOW | DE | 19702 |
| K022757 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K130080 | MEDICA CORPORATION |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K070835 | OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH |
LISMEEHAN | O'CALLAGHANS MILLS, CO. CLARE | ||
| K140404 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K132571 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K022654 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K143720 | Siemens Healthcare Diagnostics |
500 GBC Drive | Newark | DE | 19714 |
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