FDA 510(k) Applications Submitted by Diana Dickson
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160090 |
01/15/2016 |
Lumipulse G ROMA |
Fujirebio Diagnostics, Inc. |
| K070820 |
03/26/2007 |
ARCHITECT TACROLIMUS: MODEL 1L77 |
FUJIREBIO DIAGNOSTICS, INC. |
| K151378 |
05/22/2015 |
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators |
Fujirebio Diagnostics, Inc. |
| K151502 |
06/04/2015 |
ARCHITECT ROMA |
Fujirebio Diagnostics, Inc. |
| K142895 |
10/03/2014 |
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators |
FUJIREBIO DIAGNOSTICS, INC |
| K153145 |
10/30/2015 |
Lumipulse G TP-N Immunoreaction Cartridge Set |
Fujirebio Diagnostics, Inc. |
| K163521 |
12/15/2016 |
Lumipulse G LH Calibrators |
FUJIREBIO DIAGNOSTICS, INC |
| K103676 |
12/16/2010 |
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL |
FUJIREBIO DIAGNOSTICS, INC. |
| K072939 |
10/17/2007 |
HE4 EIA, MODEL: 404-10 US |
FUJIREBIO DIAGNOSTICS, INC. |
| K103358 |
11/16/2010 |
ROMA (HE4 EIA + ARCHITECT CA 125 II) |
FUJIREBIO DIAGNOSTICS, INC. |
| K070822 |
03/26/2007 |
ARCHITECT SIROLIMUS ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
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