Cleared Traditional

SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2

K112491 · Sebia · Hematology
May 2012
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K112491 is an FDA 510(k) clearance for the SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Sebia (Evry, FR). The FDA issued a Cleared decision on May 24, 2012, 269 days after receiving the submission on August 29, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K112491 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2011
Decision Date May 24, 2012
Days to Decision 269 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GKA — Abnormal Hemoglobin Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

Similar Devices — GKA Abnormal Hemoglobin Quantitation

All 22
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
K232027 · Sebia · Apr 2024
Premier Resolution System
K222635 · Trinity Biotech (Primus Corporation, Dba Trinity Biotech) · Aug 2023
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
K192931 · Helena Laboratories, Corp. · Apr 2022
CAPI 3 HEMOGLOBIN(E)
K180762 · Sebia · Dec 2018
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
K171664 · Bio-Rad Laboratories, Inc. · Sep 2017
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
K112550 · Sebia · May 2012