FDA 510(k) Applications for Medical Device:
Test, Factor V Leiden Mutations, Genomic Dna Pcr
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K060564 | AUTOGENOMICS, INC |
2251 RUTHERFORD ROAD | CARLSBAD | CA | 92008 |
| K082118 | CEPHEID |
904 CARIBBEAN DRIVE | SUNNYVALE | CA | 94089-1189 |
| K100980 | HOLOGIC, INC. |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K093129 | ILLUMINA, INC. |
9865 TOWNE CENTRE DRIVE | SAN DIEGO | CA | 92121-1975 |
| K093974 | OSMETECH MOLECULAR DIAGNOSTICS |
757 SOUTH RAYMOND AVE. | PASADENA | CA | 91105 |
| DEN030005 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
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