FDA 510(k) Applications for Medical Device:
Sirolimus Test System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K042411 | AXIS-SHIELD LTD. |
THE TECHNOLOGY PARK | DUNDEE, TAYSIDE, SCOTLAND | DD21XA | |
| K070822 | FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PARKWAY | MALVERN | PA | 19355-1308 |
| DEN040008 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K083487 | SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K081857 | Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
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