FDA 510(k) Applications for Medical Device Product Code "JFL"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K191298 | Abbott Point of Care Inc. | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 02/07/2020 |
K014034 | BECKMAN COULTER, INC. | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) | 12/18/2001 |
K040975 | GENCHEM, INC. | GENCHEM CO2 ACID REAGENT | 12/27/2004 |
K963005 | NOVA BIOMEDICAL CORP. | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) | 08/23/1996 |
K963541 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS CO2 ACID REAGENT | 10/24/1996 |
K963538 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | 10/11/1996 |
K963540 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS ELECTROLYTE BUFFER | 09/27/1996 |