Product code JFL
- Device name
- Ph Rate Measurement, Carbon-Dioxide
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1160
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-07 |
| K040975 | GENCHEM CO2 ACID REAGENT | Genchem, Inc. | 2004-12-27 |
| K014034 | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) | Beckman Coulter, Inc. | 2001-12-18 |
| K963541 | SIGMA DIAGNOSTICS CO2 ACID REAGENT | Sigma Diagnostics, Inc. | 1996-10-24 |
| K963538 | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | Sigma Diagnostics, Inc. | 1996-10-11 |
| K963540 | SIGMA DIAGNOSTICS ELECTROLYTE BUFFER | Sigma Diagnostics, Inc. | 1996-09-27 |
| K963005 | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) | Nova Biomedical Corp. | 1996-08-23 |
| K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT | Sigma Chemical Co. | 1994-01-03 |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Sigma Chemical Co. | 1993-12-17 |
| K933692 | SIGMA CO2 ACID REAGENT | Sigma Chemical Co. | 1993-12-09 |
| K933695 | SIGMA ELECTROLYTE BUFFER | Sigma Chemical Co. | 1993-10-22 |
| K925552 | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 | Hichem Diagnostics | 1993-02-12 |
| K925553 | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 | Hichem Diagnostics | 1993-02-12 |
| K900185 | NIIC MODEL: DX901 ASPIRATION SYSTEM | Niic U.S.A., Inc. | 1990-05-24 |
| K897183 | SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS | Beckman Instruments, Inc. | 1990-03-30 |
| K900420 | BICARBONATE REAGENTS PRODUCT #7713 & #7714 | American Research Products Co. | 1990-03-01 |
| K873129 | CARBON DIOXIDE REAGENT KIT | A-Kem, Inc. | 1987-10-23 |
| K842656 | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL | Shaban Mfg. Co. | 1984-08-12 |
| K822117 | FERMCOTEST CO2 REAGNET | Fermco Biochemics, Inc. | 1982-09-30 |
| K820388 | LIQUIZYME CO2REAGENT SET | American Research Products Co. | 1982-03-08 |
| K811381 | ASTRA | Chem-Elec, Inc. | 1981-08-13 |
| K802035 | BAKER DIAG. ULTRARATE CO2 REAGENT KIT | J.T. Baker Chemical Co. | 1980-09-26 |
| K800586 | NSI CARBON DIOXIDE REAGENT KIT | Nobel Scientific Industries, Inc. | 1980-04-04 |
| K800218 | CARBON DIOXIDE CUP REAGENT & REF.RGT. | Fisher Scientific Co., LLC | 1980-02-26 |
| K792254 | NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE | Nova Biomedical Corp. | 1979-12-06 |
| K791687 | CO2 REFERENCE REAGENT | Hi Chem, Inc. | 1979-09-17 |
| K791686 | CO2 CUP REAGENT | Hi Chem, Inc. | 1979-09-17 |
| K771592 | STAT/LYTE ANALYZER | Technicon Instruments Corp. | 1977-10-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811403015955 | Flush Solution | Diamond Diagnostics Inc. | 2023-06-05 |
| 00630414606460 | epoc Host2 | Epocal Inc | 2020-07-15 |
| 00630414606095 | epoc NXS Host | Epocal Inc | 2020-06-18 |
| 10054749005519 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-05-01 |
| 00385480183420 | NOVA | NOVA BIOMEDICAL CORPORATION | 2017-04-24 |
| 00842768014307 | Dimension® QuikLYTE® Multisensor Flush Solution | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768014291 | Dimension® QuikLYTE® Multisensor Na+/K+/Cl- | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768014024 | Dimension® QuikLYTE® Integrated Multisensor Diluent Check | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00385480001250 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480539852 | Nova | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480215886 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480165013 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480142441 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480141871 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480128827 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480131926 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480141826 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480140829 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480131940 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480068574 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480112727 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480127042 | NOVA/STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131421 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480178792 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480175180 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480175142 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170932 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170925 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480142533 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00817302020670 | ISE ELECTROLYTE REFERENCE 88811 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |