FDA 510(k) Applications Submitted by AXIS-SHIELD DIAGNOSTICS, LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| 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. |
| K020156 |
01/17/2002 |
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K020687 |
03/04/2002 |
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K031177 |
04/14/2003 |
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K021516 |
05/10/2002 |
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K023285 |
09/16/2002 |
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K020348 |
02/04/2002 |
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K020349 |
02/04/2002 |
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K062467 |
08/24/2006 |
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K063347 |
11/06/2006 |
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K033606 |
11/17/2003 |
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K112790 |
09/26/2011 |
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K121946 |
07/03/2012 |
AXIS-SHIELD ACVTIVE-B12 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K041866 |
07/09/2004 |
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) |
AXIS-SHIELD DIAGNOSTICS, LTD. |
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