Cleared Traditional

HICHEM ISEKCI SOLUTION KIT 70010

K953862 · Hichem Diagnostics · Chemistry
Sep 1995
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K953862 is an FDA 510(k) clearance for the HICHEM ISEKCI SOLUTION KIT 70010, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on September 6, 1995, 20 days after receiving the submission on August 17, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K953862 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1995
Decision Date September 06, 1995
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

Similar Devices — CGZ Electrode, Ion-specific, Chloride

All 37
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
K182072 · Ortho-Clinical Diagnostics, Inc. · Oct 2018
Alinity c ICT Sample Diluent
K170320 · Abbott Laboratories · Oct 2017
VITROS Chemistry Products Cl- Slides
K162020 · Ortho-Clinical Diagnostics · Dec 2016
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
K082099 · Ortho-Clinical Diagnostics, Inc. · Aug 2008
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
K070889 · Wallac OY · Apr 2008
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
K070531 · Thermo Fisher Scientific · Sep 2007