CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C— 510(k) K122101

Name: FDA 510(k) clearance K122101
Creator: U.S. Food and Drug Administration
Published: 2012-12-06

Substantially Equivalent

Sebia

FDA 510(k) clearance K122101 for CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C, Substantially Equivalent on 2012-12-06. Applicant: Sebia. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2012-07-16
Decision date: 2012-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCP

view all

K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer2024-11-22
K231465 — Q-Pad Test System2023-12-06
K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer2023-09-27
K192987 — Aina HbA1c Monitoring System 22020-03-26
K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit2019-10-29

More clearances from Sebia

view all

K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument2024-04-04
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

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