Home / 510(k) Clearances / K980996

510(k) K980996

COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) by Roche Diagnostic Systems, Inc. — Product Code KHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1998
Date Received
March 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by Roche Diagnostic Systems, Inc.

  • K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES (May 3, 1999)
  • K983702 — MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES (February 11, 1999)
  • K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (February 10, 1999)
  • K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS (December 15, 1998)
  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
  • K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (December 11, 1998)
  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (December 11, 1998)
  • K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (December 11, 1998)

Other clearances for product code KHS

  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K152085 — Liquid CO2-2 (LCO2-2) (February 24, 2016)
  • K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (March 11, 2014)
  • K131546 — AU BICARBONATE REAGENT (October 9, 2013)
  • K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REA (May 2, 2013)
  • K120765 — VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (October 24, 2012)
  • K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILI (July 2, 2012)
  • K111960 — ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE (November 18, 2011)
  • K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77 (December 15, 2010)
  • K100289 — ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, (May 10, 2010)