Company ยท US
Sebia
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2024. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 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 Isoenzymes | 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 Phosphatase Isoenzymes | 1 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 1 |
| JHO | Electrophoretic Separation, Lipoproteins | 1 |
| OBZ | Alpha-1-Antitrypsin Kit, Qualitative Phenotype | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2024 | K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument Sebia | GKA |
| Feb 23, 2024 | K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 Sebia | DFH |
| Nov 18, 2022 | K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 Sebia | DFH |
| Nov 12, 2021 | K203184 | HYDRASHIFT 2/4 isatuximab Sebia | CFF |
| Nov 1, 2019 | K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera Sebia | CFF |
| May 2, 2019 | K190851 | HYDRASHIFT 2/4 daratumumab Sebia | CFF |
| Dec 14, 2018 | K180762 | CAPI 3 HEMOGLOBIN(E) Sebia | GKA |
| Feb 7, 2018 | K171861 | CAPILLARYS Hb A1c Sebia | PDJ |
| Jan 11, 2018 | K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control Sebia | CFF |
| Sep 12, 2017 | K171537 | CAPI 3 Hb A1c Sebia | PDJ |
| Feb 17, 2017 | K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) Sebia | LCP |
| Dec 21, 2016 | K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL Sebia | CFF |
| Jan 8, 2015 | K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING Sebia | CFF |
| Mar 28, 2014 | K133344 | MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS Sebia | LCP |
| Jul 26, 2013 | K130500 | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT Sebia | CEF |
| Dec 6, 2012 | K122101 | CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C Sebia | LCP |
| May 25, 2012 | K112550 | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM Sebia | GKA |
| May 24, 2012 | K112491 | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 Sebia, FR | GKA |
| Nov 7, 2011 | K101863 | IT/IF CONTROL Sebia | JJY |
| Aug 31, 2010 | K100307 | GELSCAN, MODEL 1206 Sebia | CFE |
| Feb 22, 2010 | K091283 | CAPILLARYS NEONAT HB (PN 2006) Sebia | GKA |
| Apr 17, 2009 | K082085 | CAPILLARYS IMMUNOTYPING, MODEL 2100 Sebia | CFF |
| Apr 14, 2009 | K082388 | MINICAP IMMUNOTYPING, MODEL: 2300 Sebia | CFF |
| Mar 26, 2009 | K082227 | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 Sebia | GKA |
| Jul 1, 2008 | K080916 | CAPILLARYS URINE Sebia | JKM |
| Dec 21, 2007 | K070486 | CAPILLARYS URINE (PN 2012) Sebia, Inc. | JKM |
| Jun 11, 2007 | K063498 | HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) Sebia | OBZ |
| Jun 27, 2006 | K052291 | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) Sebia | GKA |
| Jun 27, 2005 | K042939 | CAPILLARY'S IMMUNOTYPING (PN 2100) Sebia, Inc. | DFH |
| Apr 28, 2004 | K040925 | NORMAL AND HYPERGAMMA CONTROL SERUM Sebia | JJY |
| Jul 12, 2002 | K022053 | HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 Sebia | JHO |
| Jun 13, 2001 | K011113 | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) Sebia | CIN |
| Mar 10, 1997 | K970477 | HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT Sebia | CFE |
| Jun 30, 1995 | K951536 | HYDRAGEL PROTEIN(E) KIT Sebia | CEF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2006 | Sebia, Inc. HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France Terminated |
JBD | K991362 |