Electrode, Ion Specific
FDA 510(k) K915675 · Alko Diagnostic Corp.
510(k) numberK915675
Submission
- Device name
- Electrode, Ion Specific
- Applicant
- Alko Diagnostic Corp.
Holliston, MA, US - Received
- December 19, 1991
- Decision date
- April 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFP – Electrode, Ion Specific, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
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| 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 |
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| K982501 | Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent…JIX · Traditional | 09/01/1998SE |
| K972004 | Ise Reagents for Olympus Au 800/AU5200 Chemistry SystemsCGZ · Traditional | 06/16/1997SE |
| K970921 | Standard a Multiply (A540-0), Standard B Multiply (A550-0), Standard C Multiply (A560-0)JIX · Traditional | 04/08/1997SE |
| K962864 | THB Cal Standard for Il Co-Oximeters/OximetersKRZ · Traditional | 12/18/1996SE |
| K963734 | Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry SystemsCGZ · Traditional | 10/24/1996SE |
| K960085 | Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak SystemsJIX · Traditional | 03/11/1996SE |
| K955154 | Cal 1 & Cal 2 Solution, Flush Solution KitJIX · Traditional | 12/11/1995SE |
| K951071 | Alko Slope THB Solution for Corning 280, 288 and 2500 AnalyzersKRZ · Traditional | 07/24/1995SE |
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Questions and answers
When was Electrode, Ion Specific cleared by the FDA?
Electrode, Ion Specific (K915675) received a 510(k) decision of Substantially Equivalent on April 29, 1992, 132 days after the submission was received.
What is the product code of K915675?
The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.