FDA 510(k) Applications Submitted by Stacey Dolan
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K100831 |
03/24/2010 |
CYFRA 21-1 EIA MODEL 211-10 |
FUJIREBIO DIAGNOSTICS, INC |
| K171103 |
04/13/2017 |
Lumipulse G TSH-III Immunoreaction Cartridges |
Fujirebio Diagnostics, Inc. |
| K101809 |
06/29/2010 |
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 |
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. |
| K242706 |
09/09/2024 |
Lumipulse G pTau217/▀-Amyloid 1-42 Plasma Ratio |
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. |
| 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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