Electrode, Ion Specific, Calcium
FDA product code JFP · Class II (moderate risk) · 21 CFR 862.1145 · Clinical Chemistry
29510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Nova Biomedical Corp. 6
- Avl Scientific Corp. 4
- Medica Corp. 3
- Ionetics, Inc. 2
- Amdev, Inc. 2
- Abbott Point Of Care Inc. 2
- The London Co. 1
- Applied Medical Technologies 1
- Corning Medical & Scientific 1
- Ilex Corp. 1
- Kone Instruments, Inc. 1
- The Rupp & Bowman Co. 1
- Instrumentation Laboratory CO 1
- Eos Technology Corp. 1
- Alko Diagnostic Corp. 1
- I-Stat Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFP · Traditional | Abbott Point of Care, Inc. | 02/14/2020SE |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer SystemJFP · Traditional | Nova Biomedical Corporation | 08/16/2019SE |
| K152327 | EasyLyte Na/K/Cl/Ca AnalyzerJFP · Traditional | Medica Corporation | 12/01/2016SE |
| K984299 | Avl Opti Critical Care AnalyzerJFP · Traditional | Avl Scientific Corp. | 12/11/1998SE |
| K972673 | Avl 9181 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 08/20/1997SE |
| K963694 | Easylyte Calcium/Chloride AnalyzerJFP · Traditional | Medica Corp. | 11/27/1996SE |
| K961458 | Avl 9180 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 06/12/1996SE |
| K960120 | Stat Profile Ultra F,G,H,I,J, and K AnalyzersJFP · Traditional | Nova Biomedical Corp. | 03/11/1996SE |
| K943091 | Easy Lyte Calcium AnalyzerJFP · Traditional | Medica Corp. | 01/17/1995SE |
| K943702 | Avl 988-4 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 09/09/1994SE |
| K934642 | I-Stat Ionized Calcium TestJFP · Traditional | I-Stat Corp. | 12/17/1993SE |
| K915675 | Electrode, Ion SpecificJFP · Traditional | Alko Diagnostic Corp. | 04/29/1992SE |
| K904726 | Lytening TM 6/RJFP · Traditional | Amdev, Inc. | 12/18/1990SE |
| K896316 | Eos Ionized Calcium Test CardJFP · Traditional | Eos Technology Corp. | 02/13/1990SE |
| K895397 | Calcium and PH Electrolyte AnalyzerJFP · Traditional | Ionetics, Inc. | 12/12/1989SE |
| K884771 | Il Phoenix, Model 900, Chemistry/Electrolyte AnalyJFP · Traditional | Instrumentation Laboratory CO | 02/10/1989SE |
| K884731 | Lytening 6 Sodium/Potassium/Ionized Calcium AnalyzJFP · Traditional | Amdev, Inc. | 02/03/1989SE |
| K880973 | Microlyte 7JFP · Traditional | The Rupp & Bowman Co. | 09/07/1988SE |
| K873345 | 'Microlyte 4/5'JFP · Traditional | Kone Instruments, Inc. | 09/11/1987SE |
| K860639 | Ionized Calcium and Blood PH TestcardsJFP · Traditional | Ilex Corp. | 04/21/1986SE |
| K844188 | Corning Calcium PH Analyzer 634JFP · Traditional | Corning Medical & Scientific | 02/04/1985SE |
| K830213 | Nova 7 Total Calcium/Ionized CalciumJFP · Traditional | Nova Biomedical Corp. | 04/05/1983SE |
| K830502 | Nova 8 Ionized Calcium/Ph AnalyzerJFP · Traditional | Nova Biomedical Corp. | 03/24/1983SE |
| K823389 | Sodium/Potassium/Ionized Calcium AnalyzJFP · Traditional | Nova Biomedical Corp. | 02/02/1983SE |
| K810203 | Model Am 722JFP · Traditional | Applied Medical Technologies | 02/10/1981SE |
| K802856 | Miniature Ion Selective ElectrodesJFP · Traditional | Ionetics, Inc. | 01/28/1981SE |
| K801848 | ICA1 Ionized Calcium AnalyzerJFP · Traditional | The London Co. | 10/31/1980SE |
| K771643 | Nova 2 Ionized Calcium AnalyzerJFP · Traditional | Nova Biomedical Corp. | 09/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1098-2021 Class II | 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of…May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of… | Roche Diagnostics Operations, Inc. | 01/06/2021Terminated |
| Z-2571-2011 | Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105…Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles… | Radiometer America Inc | 04/07/2011Terminated |
| Z-0457-2009 | ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of…The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1… | Radiometer America Inc | 09/05/2008Terminated |