FDA 510(k) Applications for Medical Device Product Code "NHX"
(Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K153551 | Axis-Shield Diagnostics Limited. | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | 08/04/2016 |
| K083868 | AXIS-SHIELD DIAGNOSTICS, LTD. | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | 09/25/2009 |
| K110296 | AXIS-SHIELD DIAGNOSTICS, LTD. | AXIS-SHIELD ANTI-CCP | 08/18/2011 |
| K063347 | AXIS-SHIELD DIAGNOSTICS, LTD. | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 | 03/20/2007 |
| K023285 | AXIS-SHIELD DIAGNOSTICS, LTD. | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | 10/09/2002 |
| K021516 | AXIS-SHIELD DIAGNOSTICS, LTD. | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 | 07/23/2002 |
| K093954 | Bio-Rad Laboratories | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | 08/24/2010 |
| K112810 | Bio-Rad Laboratories | MULTI-ANALYTE DETECTION SYSTEMS | 10/26/2011 |
| K093908 | EURO-DIAGNOSTICA AB | CCPOINT | 12/01/2010 |
| K062045 | EURO-DIAGNOSTICA AB | EDIA ANTI-CCP | 12/04/2006 |
| K091657 | EURO-DIAGNOSTICA AB | IMMUNOSCAN CCPLUS | 11/19/2009 |
| K052133 | EURODIAGNOSTICA | IMMUNOSCAN RA ANTI-CCP TEST SYSTEM | 12/12/2005 |
| K070789 | EUROIMMUN US LLC | EUROIMMUN ANTI-CCP ELISA | 12/31/2007 |
| K143754 | INOVA DIAGNOSTICS, INC. | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | 09/21/2015 |
| K020414 | INOVA DIAGNOSTICS, INC. | QUANTA LITE CCP ELISA | 04/29/2002 |
| K052264 | INOVA DIAGNOSTICS, INC. | QUANTA LITE CCP3 IGG ELISA | 11/23/2005 |
| K072944 | INOVA DIAGNOSTICS, INC. | QUANTA LITE CCP3.1 IGG/IGA ELISA | 03/05/2008 |
| K081338 | Roche Diagnostics | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP | 09/11/2008 |
| K121576 | Siemens Healthcare Diagnostics Inc. | IMMULITE 2000 ANTI-CCP IGG ASSAY | 04/04/2013 |
| K061165 | SWEDEN DIAGNOSTICS (US), INC. | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 | 08/03/2006 |
| K090753 | THERATEST LABORATORIES, INC. | THERATEST EL-ANTI-CCP/2 | 03/05/2010 |
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