Cleared Traditional

COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)

K980996 · Roche Diagnostic Systems, Inc. · Chemistry
Jun 1998
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K980996 is an FDA 510(k) clearance for the COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF), a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on June 5, 1998, 80 days after receiving the submission on March 17, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K980996 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1998
Decision Date June 05, 1998
Days to Decision 80 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
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
K140248 · Hitachi Chemical Diagnostics, Inc. · Mar 2014
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