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Sebia

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories5
Latest FDA decision2024-04-04
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
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