Sebia - FDA 510(k) Cleared Devices
32
Total
32
Cleared
0
Denied
Sebia has 32 FDA 510(k) cleared medical devices. Based in Chelsea, US.
Latest FDA clearance: Apr 2024. Active since 1995. Primary specialty: Immunology.
Browse the FDA 510(k) cleared devices submitted by Sebia Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Sebia
32 devices
Cleared
Apr 04, 2024
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
Hematology
272d
Cleared
Feb 23, 2024
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
Immunology
267d
Cleared
Nov 18, 2022
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
Immunology
626d
Cleared
Nov 12, 2021
HYDRASHIFT 2/4 isatuximab
Immunology
381d
Cleared
Nov 01, 2019
CAPI 3 Immunotyping, Capillarys 3 Tera
Immunology
88d
Cleared
May 02, 2019
HYDRASHIFT 2/4 daratumumab
Immunology
30d
Cleared
Dec 14, 2018
CAPI 3 HEMOGLOBIN(E)
Hematology
266d
Cleared
Feb 07, 2018
CAPILLARYS Hb A1c
Chemistry
230d
Cleared
Jan 11, 2018
HYDRASHIFT 2/4 daratumumab, daratumumab Control
Immunology
174d
Cleared
Sep 12, 2017
CAPI 3 Hb A1c
Chemistry
110d
Cleared
Feb 17, 2017
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
Chemistry
186d
Cleared
Dec 21, 2016
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
Immunology
160d