Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Sebia

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K232027 CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA2024-04-04 View
510(k) K231601 FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH2024-02-23 View
510(k) K210623 FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH2022-11-18 View
510(k) K203184 HYDRASHIFT 2/4 isatuximabCFF2021-11-12 View
510(k) K192095 CAPI 3 Immunotyping, Capillarys 3 TeraCFF2019-11-01 View
510(k) K190851 HYDRASHIFT 2/4 daratumumabCFF2019-05-02 View
510(k) K180762 CAPI 3 HEMOGLOBIN(E)GKA2018-12-14 View
510(k) K171861 CAPILLARYS Hb A1cPDJ2018-02-07 View
510(k) K172195 HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF2018-01-11 View
510(k) K171537 CAPI 3 Hb A1cPDJ2017-09-12 View
510(k) K162281 CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)LCP2017-02-17 View
510(k) K161928 CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROLCFF2016-12-21 View
510(k) K130500 CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENTCEF2013-07-26 View
510(k) K122101 CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C CLCP2012-12-06 View
510(k) K112550 CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMGKA2012-05-25 View
510(k) K112491 SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2GKA2012-05-24 View
510(k) K101863 IT/IF CONTROLJJY2011-11-07 View
510(k) K100307 GELSCAN, MODEL 1206CFE2010-08-31 View
510(k) K091283 CAPILLARYS NEONAT HB (PN 2006)GKA2010-02-22 View
510(k) K082085 CAPILLARYS IMMUNOTYPING, MODEL 2100CFF2009-04-17 View
↑