Ph Rate Measurement, Carbon-Dioxide
FDA product code JFL · Class II (moderate risk) · 21 CFR 862.1160 · Clinical Chemistry
28510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Sigma Chemical Co. 4
- Sigma Diagnostics, Inc. 3
- Hi Chem, Inc. 2
- Nova Biomedical Corp. 2
- American Research Products Co. 2
- Hichem Diagnostics 2
- Abbott Point Of Care Inc. 1
- Technicon Instruments Corp. 1
- Genchem, Inc. 1
- Beckman Coulter Inc. 1
- Niic U.S.A., Inc. 1
- Beckman Instruments, Inc. 1
- A-Kem, Inc. 1
- Shaban Mfg. Co. 1
- Fermco Biochemics, Inc. 1
- Chem-Elec, Inc. 1
- J.T. Baker Chemical Co. 1
- Nobel Scientific Industries, Inc. 1
- Fisher Scientific Co., LLC 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFL · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K040975 | Genchem CO2 Acid ReagentJFL · Traditional | Genchem, Inc. | 12/27/2004SE |
| K014034 | Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)JFL · Special | Beckman Coulter, Inc. | 12/18/2001SE |
| K963541 | Sigma Diagnostics CO2 Acid ReagentJFL · Traditional | Sigma Diagnostics, Inc. | 10/24/1996SE |
| K963538 | Sigma Diagnostics CO2ALKALINE BufferJFL · Traditional | Sigma Diagnostics, Inc. | 10/11/1996SE |
| K963540 | Sigma Diagnostics Electrolyte BufferJFL · Traditional | Sigma Diagnostics, Inc. | 09/27/1996SE |
| K963005 | Nova 16 Analyzer (Modification Point of Care Usage)JFL · Traditional | Nova Biomedical Corp. | 08/23/1996SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | Sigma Chemical Co. | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | Sigma Chemical Co. | 12/17/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | Sigma Chemical Co. | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | Sigma Chemical Co. | 10/22/1993SE |
| K925553 | Hi Chem CO2 Alkaline Buffer Reagent KIT,PROD#88813JFL · Traditional | Hichem Diagnostics | 02/12/1993SE |
| K925552 | Hi Chem CO2 Acid Reagent Kit,Product Number 88812JFL · Traditional | Hichem Diagnostics | 02/12/1993SE |
| K900185 | Niic Model: DX901 Aspiration SystemJFL · Traditional | Niic U.S.A., Inc. | 05/24/1990SE |
| K897183 | Synchron El-Ise(Tm) Electrolyte SystemsJFL · Traditional | Beckman Instruments, Inc. | 03/30/1990SE |
| K900420 | Bicarbonate Reagents Product #7713 & #7714JFL · Traditional | American Research Products Co. | 03/01/1990SE |
| K873129 | Carbon Dioxide Reagent KitJFL · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K842656 | Replacement Parts Nova Electrolyte AnalJFL · Traditional | Shaban Mfg. Co. | 08/12/1984SE |
| K822117 | Fermcotest CO2 ReagnetJFL · Traditional | Fermco Biochemics, Inc. | 09/30/1982SE |
| K820388 | Liquizyme CO2REAGENT SetJFL · Traditional | American Research Products Co. | 03/08/1982SE |
| K811381 | AstraJFL · Traditional | Chem-Elec, Inc. | 08/13/1981SE |
| K802035 | Baker Diag. Ultrarate CO2 Reagent KitJFL · Traditional | J.T. Baker Chemical Co. | 09/26/1980SE |
| K800586 | Nsi Carbon Dioxide Reagent KitJFL · Traditional | Nobel Scientific Industries, Inc. | 04/04/1980SE |
| K800218 | Carbon Dioxide Cup Reagent & Ref.Rgt.JFL · Traditional | Fisher Scientific Co., LLC | 02/26/1980SE |
| K792254 | Nova 3+3 Chloride/Total Carbon DioxideJFL · Traditional | Nova Biomedical Corp. | 12/06/1979SE |
| K791687 | CO2 Reference ReagentJFL · Traditional | Hi Chem, Inc. | 09/17/1979SE |
| K791686 | CO2 Cup ReagentJFL · Traditional | Hi Chem, Inc. | 09/17/1979SE |
| K771592 | Stat/Lyte AnalyzerJFL · Traditional | Technicon Instruments Corp. | 10/18/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2136-2020 Class II | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product…Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or… | Beckman Coulter Inc. | 01/29/2020Terminated |