FDA 510(k) Applications Submitted by FUJIREBIO DIAGNOSTICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020566 |
02/20/2002 |
FUJIREBIO DIAGNOSTICS CA 19-9 RIA |
FUJIREBIO DIAGNOSTICS, INC. |
| K163534 |
12/16/2016 |
Lumipulse G FSH-N Calibrators |
Fujirebio Diagnostics, Inc. |
| 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. |
| K153145 |
10/30/2015 |
Lumipulse G TP-N Immunoreaction Cartridge Set |
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. |
| K060964 |
04/07/2006 |
ARCHITECT BNP ASSAY, MODEL 8K28 |
FUJIREBIO DIAGNOSTICS, INC. |
| K052000 |
07/25/2005 |
ARCHITECT CA 19-9XR ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
| K052889 |
10/13/2005 |
VITROS CA 19-9 |
FUJIREBIO DIAGNOSTICS, INC. |
| K070822 |
03/26/2007 |
ARCHITECT SIROLIMUS ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
| K092645 |
08/27/2009 |
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 |
FUJIREBIO DIAGNOSTICS, INC. |
| K133197 |
10/17/2013 |
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE |
FUJIREBIO DIAGNOSTICS, INC. |
| K123612 |
11/23/2012 |
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA |
FUJIREBIO DIAGNOSTICS, INC. |
| K042731 |
10/01/2004 |
ARCHITECT CA 125 II ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
| K042732 |
10/01/2004 |
ARCHITECT CA 15-3 ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
| K033731 |
11/28/2003 |
AXSYM CORTISOL ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
| K200997 |
04/16/2020 |
Lumipulse G CA19-9-N |
Fujirebio Diagnostics, Inc. |
| K192524 |
09/13/2019 |
Lumipulse G CA15-3 |
Fujirebio Diagnostics, Inc. |
| K140436 |
02/21/2014 |
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS |
FUJIREBIO DIAGNOSTICS, INC. |
| K190702 |
03/18/2019 |
Lumipulse G whole PTH |
Fujirebio Diagnostics, Inc. |
| K171103 |
04/13/2017 |
Lumipulse G TSH-III Immunoreaction Cartridges |
Fujirebio Diagnostics, Inc. |
| K192380 |
08/30/2019 |
ST AIA-PACK BNP |
Fujirebio Diagnostics, Inc. |
| K172713 |
09/08/2017 |
Lumipulse G BòRòAòHòMòS PCT Immunoreaction Cartridges, Lumipulse G BòRòAòHòMòS PCT Calibrators set |
Fujirebio Diagnostics, Inc. |
| K163053 |
11/01/2016 |
Lumipulse G E2-III Calibrators |
Fujirebio Diagnostics, Inc. |
| K153361 |
11/20/2015 |
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators |
FUJIREBIO DIAGNOSTICS, INC. |
| DEN200072 |
11/20/2020 |
Lumipulse G ▀-Amyloid Ratio (1-42/1-40) |
Fujirebio Diagnostics, Inc. |
| K163544 |
12/16/2016 |
Lumipulse G Prolactin |
FUJIREBIO DIAGNOSTICS, INC. |
| K163546 |
12/16/2016 |
Lumipulse G Progesterone-N Calibrators |
Fujirebio Diagnostics, Inc. |
| K080751 |
03/18/2008 |
ARCHITECT CYCLOSPORINE |
FUJIREBIO DIAGNOSTICS, INC. |
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