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 Chemistry ✕
10 devices
Cleared
Feb 07, 2018
CAPILLARYS Hb A1c
Chemistry
230d
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
Mar 28, 2014
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C...
Chemistry
149d
Cleared
Dec 06, 2012
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C...
Chemistry
143d
Cleared
Aug 31, 2010
GELSCAN, MODEL 1206
Chemistry
209d
Cleared
Jul 12, 2002
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
Chemistry
18d
Cleared
Jun 13, 2001
HYDRAGEL ISO-PAL K20 (PN 3022)
Chemistry
63d
Cleared
Mar 10, 1997
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
Chemistry
31d
Cleared
Jun 30, 1995
HYDRAGEL PROTEIN(E) KIT
Chemistry
88d