KHS · Class II · 21 CFR 862.1160

FDA Product Code KHS: Enzymatic, Carbon-dioxide

Leading manufacturers include Em Diagnostic Systems, Inc., Data Medical Associates, Inc. and Diagnostic Chemicals , Ltd..

86
Total
86
Cleared
86d
Avg days
1976
Since
86 devices
73–86 of 86
Cleared Jul 01, 1986
BICARBONATE PROCEDURE
K861673
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Dec 13, 1985
RAICHEM CO2 REAGENT
K854544
Reagents Applications, Inc.
Chemistry · 30d
Cleared Apr 08, 1985
DATA ZYME CO2 PROCEDURE
K850903
Data Medical Associates, Inc.
Chemistry · 34d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR CO2
K844987
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jun 08, 1984
ENZYMATIC CO2 DIAGNOSTIC CHEMICAL
K841664
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Jun 07, 1984
DEMAND C02
K841726
Cooper Biomedical, Inc.
Chemistry · 43d
Cleared Apr 04, 1984
CARBON DIOXIDE REAGENT
K840773
American Dade
Chemistry · 56d
Cleared Jul 27, 1982
ENZYMATIC CO2
K822079
American Monitor Corp.
Chemistry · 12d
Cleared Feb 23, 1981
BICARBONATE TEST
K810356
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Oct 25, 1977
MULTISTAT III BICARBONATE TEST
K771507
Instrumentation Laboratory CO
Chemistry · 81d
Cleared Nov 01, 1976
REAGENT KIT, ENZYMATIC CO2
K760546
Beckman Instruments, Inc.
Chemistry · 63d