CHS — Coulometric Method, Carbon-Dioxide Class II

FDA Device Classification

Classification Details

Product Code
CHS
Device Class
Class II
Regulation Number
862.1160
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K926320medical analysis systemsREFLAB SYSTEM PACK LIQUID CO2 REAGENTFebruary 3, 1993
K911838roche diagnostic systemsROCHE REAGENT FOR C02July 19, 1991
K860660amrescoAMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTSMarch 14, 1986
K841080technicon instrumentsTECHNICON RA-1000 SYS CO2May 2, 1984
K811257corning medical and scientificCORNING 965 CARBON DIOXIDE ANALYZERMay 27, 1981
K802376eastman kodakKODAK EKTA-CHEM CLINICAL CHEM. SLIDESOctober 23, 1980