Sebia, Inc.
Norcross, GA, US
SEBIA, INC. appears in FDA device records in Norcross, GA. FDA records list 25 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 25 510(k) clearances for Sebia, Inc. between 2007 and 2024. The busiest year on record is 2009, with 3. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | GKA | Substantially Equivalent | |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | DFH | Substantially Equivalent | |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | DFH | Substantially Equivalent | |
| K203184 | HYDRASHIFT 2/4 isatuximab | CFF | Substantially Equivalent | |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | CFF | Substantially Equivalent | |
| K190851 | HYDRASHIFT 2/4 daratumumab | CFF | Substantially Equivalent | |
| K180762 | CAPI 3 HEMOGLOBIN(E) | GKA | Substantially Equivalent | |
| K171861 | CAPILLARYS Hb A1c | PDJ | Substantially Equivalent | |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | CFF | Substantially Equivalent | |
| K171537 | CAPI 3 Hb A1c | PDJ | Substantially Equivalent | |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | LCP | Substantially Equivalent | |
| K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | CFF | Substantially Equivalent | |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | CFF | Substantially Equivalent | |
| K133344 | MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS | LCP | Substantially Equivalent | |
| K130500 | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT | CEF | Substantially Equivalent | |
| K122101 | CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C | LCP | Substantially Equivalent | |
| K112550 | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM | GKA | Substantially Equivalent | |
| K101863 | IT/IF CONTROL | JJY | Substantially Equivalent | |
| K100307 | GELSCAN, MODEL 1206 | CFE | Substantially Equivalent | |
| K091283 | CAPILLARYS NEONAT HB (PN 2006) | GKA | Substantially Equivalent | |
| K082085 | CAPILLARYS IMMUNOTYPING, MODEL 2100 | CFF | Substantially Equivalent | |
| K082388 | MINICAP IMMUNOTYPING, MODEL: 2300 | CFF | Substantially Equivalent | |
| K082227 | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 | GKA | Substantially Equivalent | |
| K080916 | CAPILLARYS URINE | JKM | Substantially Equivalent | |
| K070486 | CAPILLARYS URINE (PN 2012) | JKM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1063666 | 3001595416 | SEBIA, INC. | 400-1705 CORPORATE DR., NORCROSS, GA 30093 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GKAAbnormal Hemoglobin Quantitation
- LCPAssay, Glycosylated Hemoglobin
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes
- CEFElectrophoretic, Protein Fractionation
- PDJHemoglobin A1c Test System
- JKMImmunochemical, Bence-Jones Protein
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)
- DFHKappa, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0073-2007 | HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France | The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain