FDA 510(k) Applications Submitted by FUJIREBIO DIAGNOSTICS, INC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K142895 |
10/03/2014 |
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators |
FUJIREBIO DIAGNOSTICS, INC |
| K163521 |
12/15/2016 |
Lumipulse G LH Calibrators |
FUJIREBIO DIAGNOSTICS, INC |
| K110641 |
03/04/2011 |
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL |
FUJIREBIO DIAGNOSTICS, INC |
| K110436 |
02/15/2011 |
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA |
FUJIREBIO DIAGNOSTICS, INC |
| K102260 |
08/10/2010 |
FDI GLUCOSE CONTROL SOLUTIONS |
FUJIREBIO DIAGNOSTICS, INC |
| K103450 |
11/24/2010 |
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE |
FUJIREBIO DIAGNOSTICS, INC |
| K100831 |
03/24/2010 |
CYFRA 21-1 EIA MODEL 211-10 |
FUJIREBIO DIAGNOSTICS, INC |
| K101809 |
06/29/2010 |
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 |
FUJIREBIO DIAGNOSTICS, INC |
| K093957 |
12/23/2009 |
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, |
FUJIREBIO DIAGNOSTICS, INC |
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