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 Hi Chem, Inc..

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 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 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 Aug 12, 1984
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656
Shaban Mfg. Co.
Chemistry · 33d
Cleared Mar 08, 1982
LIQUIZYME CO2REAGENT SET
K820388
American Research Products Co.
Chemistry · 26d
Cleared Sep 26, 1980
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
K802035
J.T. Baker Chemical Co.
Chemistry · 35d
Cleared Feb 26, 1980
CARBON DIOXIDE CUP REAGENT & REF.RGT.
K800218
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Dec 06, 1979
NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE
K792254
Nova Biomedical Corp.
Chemistry · 28d
Cleared Sep 17, 1979
CO2 CUP REAGENT
K791686
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CO2 REFERENCE REAGENT
K791687
Hi Chem, Inc.
Chemistry · 48d
Cleared Oct 18, 1977
STAT/LYTE ANALYZER
K771592
Technicon Instruments Corp.
Chemistry · 60d

About Product Code JFL - Regulatory Context