JFL · Class II · 21 CFR 862.1160

FDA Product Code JFL: Ph Rate Measurement, Carbon-dioxide

Leading manufacturers include Sigma Chemical Co., Sigma Diagnostics, Inc. and American Research Products Co..

28
Total
28
Cleared
78d
Avg days
1977
Since

FDA 510(k) Cleared Ph Rate Measurement, Carbon-dioxide Devices (Product Code JFL)

28 devices
1–24 of 28
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Dec 27, 2004
GENCHEM CO2 ACID REAGENT
K040975
Genchem, Inc.
Chemistry · 257d
Cleared Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
K014034
Beckman Coulter, Inc.
Chemistry · 11d
Cleared Oct 24, 1996
SIGMA DIAGNOSTICS CO2 ACID REAGENT
K963541
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 11, 1996
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
K963538
Sigma Diagnostics, Inc.
Chemistry · 37d
Cleared Sep 27, 1996
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
K963540
Sigma Diagnostics, Inc.
Chemistry · 23d
Cleared Aug 23, 1996
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
K963005
Nova Biomedical Corp.
Chemistry · 21d
Cleared Jan 03, 1994
SIGMA ELECTROLYTE REFERENCE REAGENT
K933696
Sigma Chemical Co.
Chemistry · 158d
Cleared Dec 17, 1993
SIGMA CO2 ALKALINE BUFFER REAGENT
K933691
Sigma Chemical Co.
Chemistry · 141d
Cleared Dec 09, 1993
SIGMA CO2 ACID REAGENT
K933692
Sigma Chemical Co.
Chemistry · 133d
Cleared Oct 22, 1993
SIGMA ELECTROLYTE BUFFER
K933695
Sigma Chemical Co.
Chemistry · 85d
Cleared Feb 12, 1993
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
K925552
Hichem Diagnostics
Chemistry · 101d
Cleared Feb 12, 1993
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813
K925553
Hichem Diagnostics
Chemistry · 101d
Cleared May 24, 1990
NIIC MODEL: DX901 ASPIRATION SYSTEM
K900185
Niic U.S.A., Inc.
Chemistry · 128d
Cleared Mar 30, 1990
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
K897183
Beckman Instruments, Inc.
Chemistry · 92d
Cleared Mar 01, 1990
BICARBONATE REAGENTS PRODUCT #7713 & #7714
K900420
American Research Products Co.
Chemistry · 30d
Cleared Oct 23, 1987
CARBON DIOXIDE REAGENT KIT
K873129
A-Kem, Inc.
Chemistry · 74d
Cleared Aug 12, 1984
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656
Shaban Mfg. Co.
Chemistry · 33d
Cleared Sep 30, 1982
FERMCOTEST CO2 REAGNET
K822117
Fermco Biochemics, Inc.
Chemistry · 73d
Cleared Mar 08, 1982
LIQUIZYME CO2REAGENT SET
K820388
American Research Products Co.
Chemistry · 26d
Cleared Aug 13, 1981
ASTRA
K811381
Chem-Elec, Inc.
Chemistry · 90d
Cleared Sep 26, 1980
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
K802035
J.T. Baker Chemical Co.
Chemistry · 35d
Cleared Apr 04, 1980
NSI CARBON DIOXIDE REAGENT KIT
K800586
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Feb 26, 1980
CARBON DIOXIDE CUP REAGENT & REF.RGT.
K800218
Fisher Scientific Co., LLC
Chemistry · 22d

About Product Code JFL - Regulatory Context