CAPI 3 Hb A1c— 510(k) K171537

Substantially Equivalent

Sebia

FDA 510(k) clearance K171537 for CAPI 3 Hb A1c, Substantially Equivalent on 2017-09-12. Applicant: Sebia. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2017-05-25
Decision date: 2017-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PDJ

K252749 — Medconn 8K Glycated Hemoglobin Test System2026-01-06
K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR012025-10-03
K242911 — Medconn Glycated Hemoglobin Test system2025-06-20
K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System2024-09-12
K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G82021-08-05

More clearances from Sebia

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.