Medical Device Manufacturer · US , Chelsea , MI

Sebia

32 submissions · 32 cleared · Since 1995
32
Total
32
Cleared
0
Denied

Sebia — FDA 510(k) Submissions

Sebia has submitted 32 FDA 510(k) premarket notifications since 1995, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Immunoelectrophoretic, Immunoglobulins, (g, A, M), Abnormal Hemoglobin Quantitation, Assay, Glycosylated Hemoglobin, Electrophoretic, Lactate Dehydrogenase Isoenzymes, Electrophoretic, Protein Fractionation . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
K232027 · GKA Abnormal Hemoglobin... · Hematology
Apr 2024 272d
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · DFH Kappa, Antigen,... · Immunology
Feb 2024 267d
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · DFH Kappa, Antigen,... · Immunology
Nov 2022 626d
HYDRASHIFT 2/4 isatuximab
K203184 · CFF Immunoelectrophoretic,... · Immunology
Nov 2021 381d
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095 · CFF Immunoelectrophoretic,... · Immunology
Nov 2019 88d
HYDRASHIFT 2/4 daratumumab
K190851 · CFF Immunoelectrophoretic,... · Immunology
May 2019 30d
CAPI 3 HEMOGLOBIN(E)
K180762 · GKA Abnormal Hemoglobin... · Hematology
Dec 2018 266d
CAPILLARYS Hb A1c
K171861 · PDJ Hemoglobin A1c Test System · Chemistry
Feb 2018 230d
HYDRASHIFT 2/4 daratumumab, daratumumab Control
K172195 · CFF Immunoelectrophoretic,... · Immunology
Jan 2018 174d
CAPI 3 Hb A1c
K171537 · PDJ Hemoglobin A1c Test System · Chemistry
Sep 2017 110d
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
K162281 · LCP Assay, Glycosylated... · Chemistry
Feb 2017 186d
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928 · CFF Immunoelectrophoretic,... · Immunology
Dec 2016 160d
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K143483 · CFF Immunoelectrophoretic,... · Immunology
Jan 2015 31d
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
K133344 · LCP Assay, Glycosylated... · Chemistry
Mar 2014 149d
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
K130500 · CEF Electrophoretic, Protein... · Immunology
Jul 2013 150d
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
K122101 · LCP Assay, Glycosylated... · Chemistry
Dec 2012 143d
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
K112550 · GKA Abnormal Hemoglobin... · Hematology
May 2012 267d
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
K112491 · GKA Abnormal Hemoglobin... · Hematology
May 2012 269d
IT/IF CONTROL
K101863 · JJY Multi-analyte Controls,... · Immunology
Nov 2011 493d
GELSCAN, MODEL 1206
K100307 · CFE Electrophoretic, Lactate... · Chemistry
Aug 2010 209d
CAPILLARYS NEONAT HB (PN 2006)
K091283 · GKA Abnormal Hemoglobin... · Hematology
Feb 2010 297d
CAPILLARYS IMMUNOTYPING, MODEL 2100
K082085 · CFF Immunoelectrophoretic,... · Immunology
Apr 2009 268d
MINICAP IMMUNOTYPING, MODEL: 2300
K082388 · CFF Immunoelectrophoretic,... · Immunology
Apr 2009 238d
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
K082227 · GKA Abnormal Hemoglobin... · Hematology
Mar 2009 231d
CAPILLARYS URINE
K080916 · JKM Immunochemical,... · Immunology
Jul 2008 90d
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