Panels › Clinical Chemistry › Product code JFL · Class 2
Ph Rate Measurement, Carbon-Dioxide
Regulation 862.1160
0510(k)s in 12 months (28 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in JFL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 2020 | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JFL |
| Dec 27, 2004 | K040975 | GENCHEM CO2 ACID REAGENT Genchem, Inc. | JFL |
| Dec 18, 2001 | K014034 | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) Beckman Coulter, Inc. | JFL |
| Oct 24, 1996 | K963541 | SIGMA DIAGNOSTICS CO2 ACID REAGENT Sigma Diagnostics, Inc. | JFL |
| Oct 11, 1996 | K963538 | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER Sigma Diagnostics, Inc. | JFL |
| Sep 27, 1996 | K963540 | SIGMA DIAGNOSTICS ELECTROLYTE BUFFER Sigma Diagnostics, Inc. | JFL |
| Aug 23, 1996 | K963005 | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) Nova Biomedical Corp. | JFL |
| Jan 3, 1994 | K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT Sigma Chemical Co. | JFL |
| Dec 17, 1993 | K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT Sigma Chemical Co. | JFL |
| Dec 9, 1993 | K933692 | SIGMA CO2 ACID REAGENT Sigma Chemical Co. | JFL |
| Oct 22, 1993 | K933695 | SIGMA ELECTROLYTE BUFFER Sigma Chemical Co. | JFL |
| Feb 12, 1993 | K925553 | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 Hichem Diagnostics | JFL |
| Feb 12, 1993 | K925552 | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 Hichem Diagnostics | JFL |
| May 24, 1990 | K900185 | NIIC MODEL: DX901 ASPIRATION SYSTEM Niic U.S.A., Inc. | JFL |
| Mar 30, 1990 | K897183 | SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS Beckman Instruments, Inc. | JFL |
| Mar 1, 1990 | K900420 | BICARBONATE REAGENTS PRODUCT #7713 & #7714 American Research Products Co. | JFL |
| Oct 23, 1987 | K873129 | CARBON DIOXIDE REAGENT KIT A-Kem, Inc. | JFL |
| Aug 12, 1984 | K842656 | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL Shaban Mfg. Co. | JFL |
| Sep 30, 1982 | K822117 | FERMCOTEST CO2 REAGNET Fermco Biochemics, Inc. | JFL |
| Mar 8, 1982 | K820388 | LIQUIZYME CO2REAGENT SET American Research Products Co. | JFL |
| Aug 13, 1981 | K811381 | ASTRA Chem-Elec, Inc. | JFL |
| Sep 26, 1980 | K802035 | BAKER DIAG. ULTRARATE CO2 REAGENT KIT J.T. Baker Chemical Co. | JFL |
| Apr 4, 1980 | K800586 | NSI CARBON DIOXIDE REAGENT KIT Nobel Scientific Industries, Inc. | JFL |
| Feb 26, 1980 | K800218 | CARBON DIOXIDE CUP REAGENT & REF.RGT. Fisher Scientific Co., LLC | JFL |
| Dec 6, 1979 | K792254 | NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE Nova Biomedical Corp. | JFL |
| Sep 17, 1979 | K791687 | CO2 REFERENCE REAGENT Hi Chem, Inc. | JFL |
| Sep 17, 1979 | K791686 | CO2 CUP REAGENT Hi Chem, Inc. | JFL |
| Oct 18, 1977 | K771592 | STAT/LYTE ANALYZER Technicon Instruments Corp. | JFL |
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