Sebia: FDA-registered device maker in EVRY Essonne, France, 38 510(k) clearances

Name: Sebia FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sebia is registered with the FDA (registration 8023024) in EVRY Essonne, France. It lists 28 device types. The FDA files 38 510(k) clearances under its listings, the newest dated April 4, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8023024
FEI number: 6387
Address: Parc Technologique Leonard De Vinci, EVRY Essonne, France, 91008
Owner or operator: SEBIA (8023024)
Roles: Manufacturer
First device listed: May 24, 1995
Registered through: 2026
Brand names listed: CAPI 3 HEMOGLOBIN TERA, CAPI 3 HEMOGLOBIN OCTA, CAPI 3 NEONAT HB USING THE CAPILLARYS 3 DBS INSTRUMENT, CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA, CAPILLARYS HB A1C USING CAPILLARYS 2 FLEX PIERCING, CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING, CAPILLARYS NEONAT HB, CAPi3 HbA1c, Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA and more

Devices it lists

Device	Product code	Class	Role	Source
Abnormal Hemoglobin Quantitation	GKA	2	Manufacturer	accessdata.fda.gov
Alpha-1-Antitrypsin Kit, Qualitative Phenotype	OBZ	2	Manufacturer	accessdata.fda.gov
Apparatus, Electrophoresis, For Clinical Use	JJN	1	Manufacturer	accessdata.fda.gov
Assay, Fetal Hemoglobin	KQI	2	Manufacturer	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer	accessdata.fda.gov
Colorimetric Method, Cpk Or Isoenzymes	JHY	2	Manufacturer	accessdata.fda.gov
Control, Hemoglobin, Abnormal	JCM	2	Manufacturer	accessdata.fda.gov
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	JQT	1	Manufacturer	accessdata.fda.gov
Densitometeric, Protein Fractionation	JQJ	1	Manufacturer	accessdata.fda.gov
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl	LBT	1	Manufacturer	accessdata.fda.gov
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	CIN	2	Manufacturer	accessdata.fda.gov
Electrophoretic Separation, Lipoproteins	JHO	1	Manufacturer	accessdata.fda.gov
Electrophoretic, Lactate Dehydrogenase Isoenzymes	CFE	2	Manufacturer	accessdata.fda.gov
Electrophoretic, Protein Fractionation	CEF	1	Manufacturer	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Manufacturer	accessdata.fda.gov
Hemoglobin C (Abnormal Hemoglobin Variant)	MLL	2	Manufacturer	accessdata.fda.gov
Hemoglobin S	GIQ	2	Manufacturer	accessdata.fda.gov
Immunochemical, Bence-Jones Protein	JKM	2	Manufacturer	accessdata.fda.gov
Immunoelectrophoretic, Immunoglobulins, (G, A, M)	CFF	2	Manufacturer	accessdata.fda.gov
Kappa, Antigen, Antiserum, Control	DFH	2	Manufacturer	accessdata.fda.gov
Lambda, Antigen, Antiserum, Control	DEH	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	2	Manufacturer	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Analysis, Electrophoretic Hemoglobin	JBD	2	Manufacturer	accessdata.fda.gov
Test, Carbohydrate Deficient Transferrin	NAO	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 4, 2024	K232027	CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument	GKA	Substantially Equivalent	Sebia	accessdata.fda.gov
February 23, 2024	K231601	FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2	DFH	Substantially Equivalent	Sebia	accessdata.fda.gov
November 18, 2022	K210623	FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2	DFH	Substantially Equivalent	Sebia	accessdata.fda.gov
November 12, 2021	K203184	HYDRASHIFT 2/4 isatuximab	CFF	Substantially Equivalent	Sebia	accessdata.fda.gov
November 1, 2019	K192095	CAPI 3 Immunotyping, Capillarys 3 Tera	CFF	Substantially Equivalent	Sebia	accessdata.fda.gov
May 2, 2019	K190851	HYDRASHIFT 2/4 daratumumab	CFF	Substantially Equivalent	Sebia	accessdata.fda.gov
December 14, 2018	K180762	CAPI 3 HEMOGLOBIN(E)	GKA	Substantially Equivalent	Sebia	accessdata.fda.gov
February 7, 2018	K171861	CAPILLARYS Hb A1c	PDJ	Substantially Equivalent	Sebia	accessdata.fda.gov
January 11, 2018	K172195	HYDRASHIFT 2/4 daratumumab, daratumumab Control	CFF	Substantially Equivalent	Sebia	accessdata.fda.gov
September 12, 2017	K171537	CAPI 3 Hb A1c	PDJ	Substantially Equivalent	Sebia	accessdata.fda.gov
February 17, 2017	K162281	CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)	LCP	Substantially Equivalent	Sebia	accessdata.fda.gov
December 21, 2016	K161928	CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL	CFF	Substantially Equivalent	Sebia	accessdata.fda.gov
January 8, 2015	K143483	MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING	CFF	Substantially Equivalent	Sebia	accessdata.fda.gov
March 28, 2014	K133344	MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS	LCP	Substantially Equivalent	Sebia	accessdata.fda.gov
July 26, 2013	K130500	CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT	CEF	Substantially Equivalent	Sebia	accessdata.fda.gov
December 6, 2012	K122101	CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C	LCP	Substantially Equivalent	Sebia	accessdata.fda.gov
May 25, 2012	K112550	CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM	GKA	Substantially Equivalent	Sebia	accessdata.fda.gov
May 24, 2012	K112491	SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2	GKA	Substantially Equivalent	Sebia	accessdata.fda.gov
November 7, 2011	K101863	IT/IF CONTROL	JJY	Substantially Equivalent	Sebia	accessdata.fda.gov
August 31, 2010	K100307	GELSCAN, MODEL 1206	CFE	Substantially Equivalent	Sebia	accessdata.fda.gov
February 22, 2010	K091283	CAPILLARYS NEONAT HB (PN 2006)	GKA	Substantially Equivalent	Sebia	accessdata.fda.gov
April 14, 2009	K082388	MINICAP IMMUNOTYPING, MODEL: 2300	CFF	Substantially Equivalent	Sebia	accessdata.fda.gov
March 26, 2009	K082227	MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227	GKA	Substantially Equivalent	Sebia	accessdata.fda.gov
July 1, 2008	K080916	CAPILLARYS URINE	JKM	Substantially Equivalent	Sebia	accessdata.fda.gov
June 11, 2007	K063498	HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)	OBZ	Substantially Equivalent	Sebia	accessdata.fda.gov
June 27, 2006	K052291	CAPILLARY'S HEMOGLOBIN(E) (PN 2007)	GKA	Substantially Equivalent	Sebia	accessdata.fda.gov
December 7, 2005	K053031	EXTENDSURE HBFASC CONTROL	JCM	Substantially Equivalent	Cantebury Scientific , Ltd.	accessdata.fda.gov
June 27, 2005	K042939	CAPILLARY'S IMMUNOTYPING (PN 2100)	DFH	Substantially Equivalent	Sebia, Inc.	accessdata.fda.gov
April 28, 2004	K040925	NORMAL AND HYPERGAMMA CONTROL SERUM	JJY	Substantially Equivalent	Sebia	accessdata.fda.gov
November 4, 2003	K033277	HYDRAGEL CSF ISOFOCUSING KITS	CFF	Substantially Equivalent	Morax	accessdata.fda.gov
June 13, 2001	K011113	HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)	CIN	Substantially Equivalent	Sebia	accessdata.fda.gov
December 29, 1999	K992148	HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT	CGS	Substantially Equivalent	Morax	accessdata.fda.gov
June 21, 1999	K991362	HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)	JBD	Substantially Equivalent	Morax	accessdata.fda.gov
October 7, 1998	K981048	HYDRAGEL 6 CSF KIT	CFF	Substantially Equivalent	Morax	accessdata.fda.gov
March 4, 1998	K972591	HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT	JKM	Substantially Equivalent	Morax	accessdata.fda.gov
March 10, 1997	K970477	HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT	CFE	Substantially Equivalent	Sebia	accessdata.fda.gov
July 12, 1996	K960669	HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS	CFF	Substantially Equivalent	Morax	accessdata.fda.gov
December 4, 1986	K863980	U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST	CJE	Substantially Equivalent	U. S. Diagnostics, Inc.	accessdata.fda.gov

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Updated April 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.