FDA 510(k) Applications for Medical Device:
Assay, Porphyrin, Spectrophotometry, Lithium
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K050374 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K063684 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K070987 | SENTINEL CH SPA |
VIA ROBERT KOCH 2 | MILAN | 20152 | |
| K112142 | SIEMENS HEALTHCARE DIAGNOSTICS |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K063705 | THERMO ELECTRON OY |
RATASTIE 2 | VANTAA | FIN-01621 | |
| K003583 | TRACE AMERICA, INC. |
845 AVE. G EAST | ARLINGTON | TX | 76011 |
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