Sebia - FDA 510(k) Cleared Devices

Cleared Feb 07, 2018

CAPILLARYS Hb A1c

K171861 · PDJ

Chemistry · 230d

Cleared Sep 12, 2017

CAPI 3 Hb A1c

K171537 · PDJ

Chemistry · 110d

Cleared Feb 17, 2017

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

K162281 · LCP

Chemistry · 186d

Cleared Mar 28, 2014

MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C...

K133344 · LCP

Chemistry · 149d

Cleared Dec 06, 2012

CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C...

K122101 · LCP

Chemistry · 143d

Cleared Aug 31, 2010

GELSCAN, MODEL 1206

K100307 · CFE

Chemistry · 209d

Cleared Jul 12, 2002

HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134

K022053 · JHO

Chemistry · 18d

Cleared Jun 13, 2001

HYDRAGEL ISO-PAL K20 (PN 3022)

K011113 · CIN

Chemistry · 63d

Cleared Mar 10, 1997

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT

K970477 · CFE

Chemistry · 31d

Cleared Jun 30, 1995

HYDRAGEL PROTEIN(E) KIT

K951536 · CEF

Chemistry · 88d