JFL · Ph Rate Measurement, Carbon-Dioxide
Clinical Chemistry · 21 CFR 862.1160 · Class 2
Overview
| Product Code | JFL |
|---|---|
| Device Name | Ph Rate Measurement, Carbon-Dioxide |
| Regulation | 21 CFR 862.1160 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Feb 7, 2020 | SESE |
| K040975 | GENCHEM CO2 ACID REAGENT | Genchem, Inc. | Dec 27, 2004 | SESE |
| K014034 | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) | Beckman Coulter, Inc. | Dec 18, 2001 | SESE |
| K963541 | SIGMA DIAGNOSTICS CO2 ACID REAGENT | Sigma Diagnostics, Inc. | Oct 24, 1996 | SESE |
| K963538 | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | Sigma Diagnostics, Inc. | Oct 11, 1996 | SESE |
| K963540 | SIGMA DIAGNOSTICS ELECTROLYTE BUFFER | Sigma Diagnostics, Inc. | Sep 27, 1996 | SESE |
| K963005 | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) | Nova Biomedical Corp. | Aug 23, 1996 | SESE |
| K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT | Sigma Chemical Co. | Jan 3, 1994 | SESE |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Sigma Chemical Co. | Dec 17, 1993 | SESE |
| K933692 | SIGMA CO2 ACID REAGENT | Sigma Chemical Co. | Dec 9, 1993 | SESE |
| K933695 | SIGMA ELECTROLYTE BUFFER | Sigma Chemical Co. | Oct 22, 1993 | SESE |
| K925553 | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 | Hichem Diagnostics | Feb 12, 1993 | SESE |
| K925552 | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 | Hichem Diagnostics | Feb 12, 1993 | SESE |
| K900185 | NIIC MODEL: DX901 ASPIRATION SYSTEM | Niic U.S.A., Inc. | May 24, 1990 | SESE |
| K897183 | SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS | Beckman Instruments, Inc. | Mar 30, 1990 | SESE |
| K900420 | BICARBONATE REAGENTS PRODUCT #7713 & #7714 | American Research Products Co. | Mar 1, 1990 | SESE |
| K873129 | CARBON DIOXIDE REAGENT KIT | A-Kem, Inc. | Oct 23, 1987 | SESE |
| K842656 | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL | Shaban Mfg. Co. | Aug 12, 1984 | SESE |
| K822117 | FERMCOTEST CO2 REAGNET | Fermco Biochemics, Inc. | Sep 30, 1982 | SESE |
| K820388 | LIQUIZYME CO2REAGENT SET | American Research Products Co. | Mar 8, 1982 | SESE |
Top Applicants
- Sigma Chemical Co. — 4 clearances
- Sigma Diagnostics, Inc. — 3 clearances
- American Research Products Co. — 2 clearances
- Hi Chem, Inc. — 2 clearances
- Hichem Diagnostics — 2 clearances
