JFL — Ph Rate Measurement, Carbon-Dioxide Class II
FDA product code JFL covers "Ph Rate Measurement, Carbon-Dioxide", a Class II medical device regulated under 21 CFR 862.1160. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |