Sebia
Medical device manufacturer in Norcross, GA.
34510(k) clearances
0PMA approvals
1recalls
Device types
- CFF Immunoelectrophoretic, Immunoglobulins, (G… 8
- GKA Abnormal Hemoglobin Quantitation 7
- DFH Kappa, Antigen, Antiserum, Control 3
- LCP Assay, Glycosylated Hemoglobin 3
- CEF Electrophoretic, Protein Fractionation 2
- CFE Electrophoretic, Lactate Dehydrogenase… 2
- JJY Multi-Analyte Controls, All Kinds (Assayed) 2
- JKM Immunochemical, Bence-Jones Protein 2
- PDJ Hemoglobin A1c Test System 2
- CIN Electrophoretic Separation, Alkaline… 1
- JHO Electrophoretic Separation, Lipoproteins 1
- OBZ Alpha-1-Antitrypsin Kit, Qualitative… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | 04/04/2024SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | 02/23/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | 11/18/2022SE |
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | 11/01/2019SE |
| K190851 | HYDRASHIFT 2/4 daratumumabCFF · Special | 05/02/2019SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | 12/14/2018SE |
| K171861 | CAPILLARYS Hb A1cPDJ · Traditional | 02/07/2018SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | 01/11/2018SE |
| K171537 | CAPI 3 Hb A1cPDJ · Traditional | 09/12/2017SE |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)LCP · Traditional | 02/17/2017SE |
| K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, It/If ControlCFF · Traditional | 12/21/2016SE |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGCFF · Special | 01/08/2015SE |
| K133344 | Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys…LCP · Traditional | 03/28/2014SE |
| K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, It/If Control, Capillarys 2 Flex…CEF · Traditional | 07/26/2013SE |
| K122101 | Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls…LCP · Traditional | 12/06/2012SE |
| K112550 | Capillarys Hemoglobin, Capillarys Flex Piercing SystemGKA · Traditional | 05/25/2012SE |
| K112491 | Sebia Capillarys Hemoglobin(E) with Capillarys 2GKA · Traditional | 05/24/2012SE |
| K101863 | It/If ControlJJY · Traditional | 11/07/2011SE |
| K100307 | Gelscan, Model 1206CFE · Traditional | 08/31/2010SE |
| K091283 | Capillarys Neonat HB (PN 2006)GKA · Traditional | 02/22/2010SE |
| K082085 | Capillarys Immunotyping, Model 2100CFF · Traditional | 04/17/2009SE |
| K082388 | Minicap Immunotyping, Model: 2300CFF · Traditional | 04/14/2009SE |
| K082227 | Minicap Hemoglobin(E) Kit, Model 2207, 2227GKA · Traditional | 03/26/2009SE |
| K080916 | Capillarys UrineJKM · Special | 07/01/2008SE |
| K070486 | Capillarys Urine (PN 2012)JKM · Traditional | 12/21/2007SE |
| K063498 | Hydragel 18 A1AT Isofocusing Kit (PN 4356)OBZ · Traditional | 06/11/2007SE |
| K052291 | Capillary's Hemoglobin(E) (PN 2007)GKA · Traditional | 06/27/2006SE |
| K042939 | Capillary's Immunotyping (PN 2100)DFH · Traditional | 06/27/2005SE |
| K040925 | Normal and Hypergamma Control SerumJJY · Traditional | 04/28/2004SE |
| K022053 | Hydragel 7 Lipoprotein(E), PN 4114 & Hydragel Lipoprotein(E) 15/30 PN 4134JHO · Special | 07/12/2002SE |
| K011113 | Hydragel Iso-Pal K20 (PN 3022); Hydragel 7 Iso-Pal (PN 4112); Hydragel 15 Iso-Pal (PN…CIN · Traditional | 06/13/2001SE |
| K970477 | Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh KitCFE · Traditional | 03/10/1997SE |
| K951536 | Hydragel Protein(E) KitCEF · Traditional | 06/30/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0073-2007 | HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique…The material used in packaging the product results in the presence of an additional artifact band above the… | 08/29/2006Terminated |