PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT— 510(k) K103788

Clearance details

Applicant

HORIBA ABX SAS

Product code

Code CFR

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2010-12-27

Decision date

2011-11-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montpellier, FR

• K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions2026-02-12
• K252357 — Glucose22025-10-24
• K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH2022-09-16
• K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions2019-08-16
• K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM2017-10-19

• K232946 — Yumizen H25002024-05-21
• K193649 — Yumizen C1200 Creatinine PAP2021-05-10
• K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M2020-06-26
• K192028 — Yumizen C1200 CRP2020-06-25
• K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor2020-03-06

• Z-0633-2013 — PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.Class II·Terminated·Horiba Instruments, Inc dba Horiba Medical·20121010

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103788.