Cleared Traditional

AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112

K070889 · Wallac OY · Chemistry
Apr 2008
Decision
381d
Days
Class 2
Risk

About This 510(k) Submission

K070889 is an FDA 510(k) clearance for the AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on April 14, 2008, 381 days after receiving the submission on March 30, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K070889 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2007
Decision Date April 14, 2008
Days to Decision 381 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
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
K070531 · Thermo Fisher Scientific · Sep 2007
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
K060108 · Roche Diagnostics Corp. · Feb 2006