Product code JFL— Clinical Chemistry
ASTRA
- Classification name
- Ph Rate Measurement, Carbon-Dioxide
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code JFL
FDA has cleared devices under product code JFL between 1977 and 2020, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 2004
- 2001
- 1996
- 1994
- 1993
- 1990
- 1987
- 1984
- 1982
- 1981
- 1980
- 1979
- 1977
Top applicants under product code JFL
Recent clearances under product code JFL
- K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K040975 — GENCHEM CO2 ACID REAGENT
- K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
- K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT
- K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
- K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
- K963005 — NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
- K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT
- K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT
- K933692 — SIGMA CO2 ACID REAGENT
- K933695 — SIGMA ELECTROLYTE BUFFER
- K925552 — HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
- K925553 — HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813
- K900185 — NIIC MODEL: DX901 ASPIRATION SYSTEM
- K897183 — SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
- K900420 — BICARBONATE REAGENTS PRODUCT #7713 & #7714
- K873129 — CARBON DIOXIDE REAGENT KIT
- K842656 — REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
- K822117 — FERMCOTEST CO2 REAGNET
- K820388 — LIQUIZYME CO2REAGENT SET
- K811381 — ASTRA
- K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT
- K800586 — NSI CARBON DIOXIDE REAGENT KIT
- K800218 — CARBON DIOXIDE CUP REAGENT & REF.RGT.
- K792254 — NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE
- K791686 — CO2 CUP REAGENT
- K791687 — CO2 REFERENCE REAGENT
- K771592 — STAT/LYTE ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.