Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sebia — Predicate Candidate Screening

32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

203 daysmedian FDA review time

308 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days
K232027	CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument	Sebia	2024-04-04	272
K231601	FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level	Sebia	2024-02-23	267
K210623	FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Leve	Sebia	2022-11-18	626
K203184	HYDRASHIFT 2/4 isatuximab	Sebia	2021-11-12	381
K192095	CAPI 3 Immunotyping, Capillarys 3 Tera	Sebia	2019-11-01	88
K190851	HYDRASHIFT 2/4 daratumumab	Sebia	2019-05-02	30
K180762	CAPI 3 HEMOGLOBIN(E)	Sebia	2018-12-14	266
K171861	CAPILLARYS Hb A1c	Sebia	2018-02-07	230
K172195	HYDRASHIFT 2/4 daratumumab, daratumumab Control	Sebia	2018-01-11	174
K171537	CAPI 3 Hb A1c	Sebia	2017-09-12	110
K162281	CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)	Sebia	2017-02-17	186
K161928	CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL	Sebia	2016-12-21	160
K143483	MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-	Sebia	2015-01-08	31
K133344	MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CON	Sebia	2014-03-28	149
K130500	CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONT	Sebia	2013-07-26	150
K122101	CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPIL	Sebia	2012-12-06	143
K112550	CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM	Sebia	2012-05-25	267
K112491	SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2	Sebia	2012-05-24	269
K101863	IT/IF CONTROL	Sebia	2011-11-07	493
K100307	GELSCAN, MODEL 1206	Sebia	2010-08-31	209
K091283	CAPILLARYS NEONAT HB (PN 2006)	Sebia	2010-02-22	297
K082085	CAPILLARYS IMMUNOTYPING, MODEL 2100	Sebia	2009-04-17	268
K082388	MINICAP IMMUNOTYPING, MODEL: 2300	Sebia	2009-04-14	238
K082227	MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227	Sebia	2009-03-26	231
K080916	CAPILLARYS URINE	Sebia	2008-07-01	90
K063498	HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)	Sebia	2007-06-11	203
K052291	CAPILLARY'S HEMOGLOBIN(E) (PN 2007)	Sebia	2006-06-27	308
K040925	NORMAL AND HYPERGAMMA CONTROL SERUM	Sebia	2004-04-28	20
K022053	HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E)	Sebia	2002-07-12	18
K011113	HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112)	Sebia	2001-06-13	63
K970477	HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT	Sebia	1997-03-10	31
K951536	HYDRAGEL PROTEIN(E) KIT	Sebia	1995-06-30	88

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda