CHS · Class II · 21 CFR 862.1160

FDA Product Code CHS: Coulometric Method, Carbon-dioxide

Leading manufacturers include Amresco, Inc., Roche Diagnostic Systems, Inc. and Medical Analysis Systems, Inc..

6
Total
6
Cleared
41d
Avg days
1980
Since

FDA 510(k) Cleared Coulometric Method, Carbon-dioxide Devices (Product Code CHS)

6 devices
1–6 of 6
Cleared Feb 03, 1993
REFLAB SYSTEM PACK LIQUID CO2 REAGENT
K926320
Medical Analysis Systems, Inc.
Chemistry · 50d
Cleared Jul 19, 1991
ROCHE REAGENT FOR C02
K911838
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Mar 14, 1986
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K860660
Amresco, Inc.
Chemistry · 18d
Cleared May 02, 1984
TECHNICON RA-1000 SYS CO2
K841080
Technicon Instruments Corp.
Chemistry · 50d
Cleared May 27, 1981
CORNING 965 CARBON DIOXIDE ANALYZER
K811257
Corning Medical & Scientific
Chemistry · 22d
Cleared Oct 23, 1980
KODAK EKTA-CHEM CLINICAL CHEM. SLIDES
K802376
Eastman Kodak Company
Chemistry · 23d

About Product Code CHS - Regulatory Context