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Sebia

32 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (K232027)Sebia2024-04-04
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (K231601)Sebia2024-02-23
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (K210623)Sebia2022-11-18
HYDRASHIFT 2/4 isatuximab (K203184)Sebia2021-11-12
CAPI 3 Immunotyping, Capillarys 3 Tera (K192095)Sebia2019-11-01
HYDRASHIFT 2/4 daratumumab (K190851)Sebia2019-05-02
CAPI 3 HEMOGLOBIN(E) (K180762)Sebia2018-12-14
CAPILLARYS Hb A1c (K171861)Sebia2018-02-07
HYDRASHIFT 2/4 daratumumab, daratumumab Control (K172195)Sebia2018-01-11
CAPI 3 Hb A1c (K171537)Sebia2017-09-12
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (K162281)Sebia2017-02-17
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL (K161928)Sebia2016-12-21
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING (K143483)Sebia2015-01-08
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS (K133344)Sebia2014-03-28
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT (K130500)Sebia2013-07-26
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C (K122101)Sebia2012-12-06
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM (K112550)Sebia2012-05-25
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (K112491)Sebia2012-05-24
IT/IF CONTROL (K101863)Sebia2011-11-07
GELSCAN, MODEL 1206 (K100307)Sebia2010-08-31
CAPILLARYS NEONAT HB (PN 2006) (K091283)Sebia2010-02-22
CAPILLARYS IMMUNOTYPING, MODEL 2100 (K082085)Sebia2009-04-17
MINICAP IMMUNOTYPING, MODEL: 2300 (K082388)Sebia2009-04-14
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 (K082227)Sebia2009-03-26
CAPILLARYS URINE (K080916)Sebia2008-07-01
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) (K063498)Sebia2007-06-11
CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (K052291)Sebia2006-06-27
NORMAL AND HYPERGAMMA CONTROL SERUM (K040925)Sebia2004-04-28
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (K022053)Sebia2002-07-12
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) (K011113)Sebia2001-06-13
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (K970477)Sebia1997-03-10
HYDRAGEL PROTEIN(E) KIT (K951536)Sebia1995-06-30

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Every clearance here is in the API, with alerts when new ones post.