Sebia - FDA 510(k) Cleared Devices
Recent clearances: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument, FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2, FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
32
Total
32
Cleared
0
Denied
FDA 510(k) Regulatory Record - 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
Cleared
Jul 01, 2008
CAPILLARYS URINE
Immunology
90d
Cleared
Jun 11, 2007
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
Immunology
203d
Cleared
Apr 28, 2004
NORMAL AND HYPERGAMMA CONTROL SERUM
Immunology
20d