Sebia
Sebia holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2024.
Top product codes for Sebia
Recent clearances by Sebia
- K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
- K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
- K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
- K203184 — HYDRASHIFT 2/4 isatuximab
- K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera
- K190851 — HYDRASHIFT 2/4 daratumumab
- K180762 — CAPI 3 HEMOGLOBIN(E)
- K171861 — CAPILLARYS Hb A1c
- K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control
- K171537 — CAPI 3 Hb A1c
- K162281 — CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
- K161928 — CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
- K143483 — MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
- K133344 — MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
- K130500 — CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
- K122101 — CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
- K112550 — CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
- K112491 — SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
- K101863 — IT/IF CONTROL
- K100307 — GELSCAN, MODEL 1206
- K091283 — CAPILLARYS NEONAT HB (PN 2006)
- K082085 — CAPILLARYS IMMUNOTYPING, MODEL 2100
- K082388 — MINICAP IMMUNOTYPING, MODEL: 2300
- K082227 — MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
- K080916 — CAPILLARYS URINE
- K063498 — HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
- K052291 — CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
- K040925 — NORMAL AND HYPERGAMMA CONTROL SERUM
- K022053 — HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
- K011113 — HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
- K970477 — HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
- K951536 — HYDRAGEL PROTEIN(E) KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.