CAPILLARY'S HEMOGLOBIN(E) (PN 2007)— 510(k) K052291

Substantially Equivalent

Sebia

FDA 510(k) clearance K052291 for CAPILLARY'S HEMOGLOBIN(E) (PN 2007), Substantially Equivalent on 2006-06-27. Applicant: Sebia. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code GKA
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 2005-08-23
Decision date: 2006-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKA

K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument2024-04-04
K222635 — Premier Resolution System2023-08-04
K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control2022-04-19
K180762 — CAPI 3 HEMOGLOBIN(E)2018-12-14
K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software2017-09-13

More clearances from Sebia

K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 22024-02-23
K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 22022-11-18
K203184 — HYDRASHIFT 2/4 isatuximab2021-11-12
K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera2019-11-01
K190851 — HYDRASHIFT 2/4 daratumumab2019-05-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.