FDA 510(k) Applications Submitted by Claire Dora
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K241176 |
04/29/2024 |
Alere NT-proBNP for Alinity i Reagent Kit |
Axis-Shield Diagnostics Ltd |
| K172133 |
07/14/2017 |
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay |
Axis-Shield Diagnostics Ltd. |
| K182012 |
07/27/2018 |
ADVIA Centaur Calcitonin (CALCT) assay |
Axis-Shield Diagnostics Limited |
| K072686 |
09/24/2007 |
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K083222 |
11/03/2008 |
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K233541 |
11/03/2023 |
ARCHITECT Active-B12 (Holotranscobalamin) |
Axis-Shield Diagnostics, Ltd |
| K183088 |
11/06/2018 |
ADVIA Centaur Erythropoietin (EPO) assay |
Axis-Shield Diagnostics Limited |
| K073640 |
12/26/2007 |
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K083868 |
12/29/2008 |
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K110296 |
02/01/2011 |
AXIS-SHIELD ANTI-CCP |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K121842 |
06/25/2012 |
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K112443 |
08/24/2011 |
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K153551 |
12/11/2015 |
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. |
Axis-Shield Diagnostics Limited. |
| K160757 |
03/18/2016 |
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) |
AXIS-SHIELD DIAGNOSTICS LIMITED |
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