FDA 510(k) Applications for Medical Device:
Drug Metabolizing Enzyme Genotyping Systems
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K101683 | AUTOGENOMICS, INCORPORATED |
2980 SCOTT STREET | VISTA | CA | 92081 |
| K220026 | Genomadix Inc. |
340 Legget Drive, Suite 180 | Kanata (Ottawa) | ||
| K131565 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K170492 | Luminex Molecular Diagnostics, Inc. |
439 University Ave. | Toronto | M5G 1Y8 | |
| K130189 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K093420 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K120466 | NANOSPHERE, INC |
4088 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| DEN040011 | ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DRIVE | PLEASANTON | CA | 94588-2722 |
| K043576 | ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DRIVE | PLEASANTON | CA | 94588-2722 |
| K123891 | SPARTAN BIOSCIENCE INC |
3 LAGOON DRIVE, STE 280 | REDWOOD SHORES | CA | 94065 |
| K051824 | THIRD WAVE TECHNOLOGIES, INC. |
502 SOUTH ROSA RD. | MADISON | WI | 53719-1256 |
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