FDA Product Code
FDA Product Code JFL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1160
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-07 | Traditional | PDF ↗ |
| K040975 | GENCHEM CO2 ACID REAGENT | Genchem, Inc. | 2004-12-27 | Traditional | PDF ↗ |
| K014034 | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) | Beckman Coulter, Inc. | 2001-12-18 | Special | PDF ↗ |
| K963541 | SIGMA DIAGNOSTICS CO2 ACID REAGENT | Sigma Diagnostics, Inc. | 1996-10-24 | Traditional | PDF ↗ |
| K963538 | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | Sigma Diagnostics, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K963540 | SIGMA DIAGNOSTICS ELECTROLYTE BUFFER | Sigma Diagnostics, Inc. | 1996-09-27 | Traditional | PDF ↗ |
| K963005 | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) | Nova Biomedical Corp. | 1996-08-23 | Traditional | PDF ↗ |
| K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT | Sigma Chemical Co. | 1994-01-03 | Traditional | PDF ↗ |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Sigma Chemical Co. | 1993-12-17 | Traditional | PDF ↗ |
| K933692 | SIGMA CO2 ACID REAGENT | Sigma Chemical Co. | 1993-12-09 | Traditional | PDF ↗ |
| K933695 | SIGMA ELECTROLYTE BUFFER | Sigma Chemical Co. | 1993-10-22 | Traditional | PDF ↗ |
| K925552 | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 | Hichem Diagnostics | 1993-02-12 | Traditional | PDF ↗ |
| K925553 | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 | Hichem Diagnostics | 1993-02-12 | Traditional | PDF ↗ |
| K900185 | NIIC MODEL: DX901 ASPIRATION SYSTEM | Niic U.S.A., Inc. | 1990-05-24 | Traditional | PDF ↗ |
| K897183 | SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS | Beckman Instruments, Inc. | 1990-03-30 | Traditional | PDF ↗ |
| K900420 | BICARBONATE REAGENTS PRODUCT #7713 & #7714 | American Research Products Co. | 1990-03-01 | Traditional | PDF ↗ |
| K873129 | CARBON DIOXIDE REAGENT KIT | A-Kem, Inc. | 1987-10-23 | Traditional | PDF ↗ |
| K842656 | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL | Shaban Mfg. Co. | 1984-08-12 | Traditional | PDF ↗ |
| K822117 | FERMCOTEST CO2 REAGNET | Fermco Biochemics, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K820388 | LIQUIZYME CO2REAGENT SET | American Research Products Co. | 1982-03-08 | Traditional | PDF ↗ |
| K811381 | ASTRA | Chem-Elec, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K802035 | BAKER DIAG. ULTRARATE CO2 REAGENT KIT | J.T. Baker Chemical Co. | 1980-09-26 | Traditional | PDF ↗ |
| K800586 | NSI CARBON DIOXIDE REAGENT KIT | Nobel Scientific Industries, Inc. | 1980-04-04 | Traditional | PDF ↗ |
| K800218 | CARBON DIOXIDE CUP REAGENT & REF.RGT. | Fisher Scientific Co., LLC | 1980-02-26 | Traditional | PDF ↗ |
| K792254 | NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE | Nova Biomedical Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K791687 | CO2 REFERENCE REAGENT | Hi Chem, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K791686 | CO2 CUP REAGENT | Hi Chem, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K771592 | STAT/LYTE ANALYZER | Technicon Instruments Corp. | 1977-10-18 | Traditional | PDF ↗ |
Product code JFL · Class II · Clinical Chemistry. Data: openFDA.