Sebia - FDA 510(k) Cleared Devices
32
Total
32
Cleared
0
Denied
FDA 510(k) cleared devices by Sebia Immunology ✕
15 devices
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
Jan 11, 2018
HYDRASHIFT 2/4 daratumumab, daratumumab Control
Immunology
174d
Cleared
Dec 21, 2016
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
Immunology
160d
Cleared
Jan 08, 2015
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
Immunology
31d
Cleared
Jul 26, 2013
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2...
Immunology
150d
Cleared
Nov 07, 2011
IT/IF CONTROL
Immunology
493d
Cleared
Apr 17, 2009
CAPILLARYS IMMUNOTYPING, MODEL 2100
Immunology
268d
Cleared
Apr 14, 2009
MINICAP IMMUNOTYPING, MODEL: 2300
Immunology
238d