JFL — Ph Rate Measurement, Carbon-Dioxide Class II
FDA Device Classification
Classification Details
- Product Code
- JFL
- Device Class
- Class II
- Regulation Number
- 862.1160
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K191298 | abbott point of care | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 7, 2020 |
| K040975 | genchem | GENCHEM CO2 ACID REAGENT | December 27, 2004 |
| K014034 | beckman coulter | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) | December 18, 2001 |
| K963541 | sigma diagnostics | SIGMA DIAGNOSTICS CO2 ACID REAGENT | October 24, 1996 |
| K963538 | sigma diagnostics | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | October 11, 1996 |
| K963540 | sigma diagnostics | SIGMA DIAGNOSTICS ELECTROLYTE BUFFER | September 27, 1996 |
| K963005 | nova biomedical | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) | August 23, 1996 |
| K933696 | sigma chemical | SIGMA ELECTROLYTE REFERENCE REAGENT | January 3, 1994 |
| K933691 | sigma chemical | SIGMA CO2 ALKALINE BUFFER REAGENT | December 17, 1993 |
| K933692 | sigma chemical | SIGMA CO2 ACID REAGENT | December 9, 1993 |
| K933695 | sigma chemical | SIGMA ELECTROLYTE BUFFER | October 22, 1993 |
| K925553 | hichem diagnostics | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 | February 12, 1993 |
| K925552 | hichem diagnostics | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 | February 12, 1993 |
| K900185 | niic u.s.a | NIIC MODEL: DX901 ASPIRATION SYSTEM | May 24, 1990 |
| K897183 | beckman instruments | SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS | March 30, 1990 |
| K900420 | american research products | BICARBONATE REAGENTS PRODUCT #7713 & #7714 | March 1, 1990 |
| K873129 | a-kem | CARBON DIOXIDE REAGENT KIT | October 23, 1987 |
| K842656 | shaban mfg | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL | August 12, 1984 |
| K822117 | fermco biochemics | FERMCOTEST CO2 REAGNET | September 30, 1982 |
| K820388 | american research products | LIQUIZYME CO2REAGENT SET | March 8, 1982 |