JFL · Class II · 21 CFR 862.1160

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

Leading manufacturers include Sigma Chemical Co., Beckman Coulter, Inc. and Abbott Point of Care, 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 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 Mar 30, 1990
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
K897183
Beckman Instruments, Inc.
Chemistry · 92d

About Product Code JFL - Regulatory Context