Cleared Traditional

S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)

K140248 · Hitachi Chemical Diagnostics, Inc. · Chemistry
Mar 2014
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K140248 is an FDA 510(k) clearance for the S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2), a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on March 11, 2014, 40 days after receiving the submission on January 30, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K140248 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2014
Decision Date March 11, 2014
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

Similar Devices — KHS Enzymatic, Carbon-dioxide

All 85
Carbon Dioxide Reagent Set
K170200 · Teco Diagnostics, Inc. · Jun 2017
Liquid CO2-2 (LCO2-2)
K152085 · Randox Laboratories, Ltd. · Feb 2016
AU BICARBONATE REAGENT
K131546 · Beckman Coulter Ireland, Inc. · Oct 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K123953 · Alfa Wassermann Diagnostic Technologies, Inc. · May 2013
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765 · Ortho-Clinical Diagnostics, Inc. · Oct 2012
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K113435 · Alfa Wassermann · Jul 2012