Panels › Clinical Chemistry › Product code JFP · Class 2
Electrode, Ion Specific, Calcium
Regulation 862.1145
0510(k)s in 12 months (29 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in JFP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2021 | Roche Diagnostics Operations, Inc. 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate sol Terminated |
JFP | K961458 |
| Jun 16, 2011 | Radiometer America Inc Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) me Terminated |
JFP | K043218 K914166 +4 |
| Dec 3, 2008 | Radiometer America Inc ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024
Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lacta Terminated |
JFP | K002290 |
| Aug 10, 2006 | Radiometer America Inc Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005. Terminated |
JFP | K041874 |
| Aug 10, 2006 | Radiometer America Inc Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004. Terminated |
JFP | K002290 K980130 +2 |
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