510(k) K052133
- Device
- IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
- Applicant
- EURODIAGNOSTICA
- 510(k) number
- K052133
- Product code
- NHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-12
- Date received
- 2005-08-05
- Regulation
- 866.5775
- Classification name
- Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM L BOTELER JR.
- Address
- 1306 Bailes Ln. Suite F Frederick MD US 21701 21701
FDA Registration Numbers#
- 1421346
- 3032705
- 3039353646
- 3002800697
- 8043792
- 3003268355
- 3004973408
- 2245285
- 3005333358
- 2432235
- 9680745
- 3022178699
- 2915274
- 3002809144
- 3007118747
- 2020726
- 8032314
- 3007361513
- 2026994
- 9610566
- 3012348571
- 9610126
- 3021841051
- 9616003
- 3002806944
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NHX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | Axis-Shield Diagnostics Limited | 2016-08-04 |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | Inova Diagnostics, Inc. | 2015-09-21 |
| K121576 | IMMULITE 2000 ANTI-CCP IGG ASSAY | Siemens Healthcare Diagnostics, Inc. | 2013-04-04 |
| K112810 | MULTI-ANALYTE DETECTION SYSTEMS | Bio-Rad Laboratories | 2011-10-26 |
| K110296 | AXIS-SHIELD ANTI-CCP | Axis-Shield Diagnostics, Ltd. | 2011-08-18 |
| K093908 | CCPOINT | Euro-Diagnostica AB | 2010-12-01 |
| K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | 2010-08-24 |
| K090753 | THERATEST EL-ANTI-CCP/2 | Theratest Laboratories, Inc. | 2010-03-05 |
| K091657 | IMMUNOSCAN CCPLUS | Euro-Diagnostica AB | 2009-11-19 |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | Axis-Shield Diagnostics, Ltd. | 2009-09-25 |
| K081338 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP | Roche Diagnostics | 2008-09-11 |
| K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA | Inova Diagnostics, Inc. | 2008-03-05 |
| K070789 | EUROIMMUN ANTI-CCP ELISA | Euroimmun Us, LLC | 2007-12-31 |
| K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 | Axis-Shield Diagnostics, Ltd. | 2007-03-20 |
| K062045 | EDIA ANTI-CCP | Euro-Diagnostica AB | 2006-12-04 |
Legacy Summary#
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FDA Review#
Decision Summary