Medical Device Manufacturer · US , Chelsea , MI

Sebia - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 1995

32

Total

32

Cleared

0

Denied

FDA 510(k) cleared devices by Sebia Hematology ✕

7 devices

1-7 of 7

Cleared Apr 04, 2024

CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument

Hematology · 272d

Cleared Dec 14, 2018

CAPI 3 HEMOGLOBIN(E)

Hematology · 266d

Cleared May 25, 2012

CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM

Hematology · 267d

Cleared May 24, 2012

SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2

Hematology · 269d

Cleared Feb 22, 2010

CAPILLARYS NEONAT HB (PN 2006)

Hematology · 297d

Cleared Mar 26, 2009

MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227

Hematology · 231d

Cleared Jun 27, 2006

CAPILLARY'S HEMOGLOBIN(E) (PN 2007)

Hematology · 308d