Prolyte Electrolyte Analyzer
FDA 510(k) K070104 · Diamond Diagnostics, Inc.
510(k) numberK070104
Submission
- Device name
- Prolyte Electrolyte Analyzer
- Applicant
- Diamond Diagnostics, Inc.
Holliston, MA, US - Received
- January 10, 2007
- Decision date
- May 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
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| K133751 | Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsJIT · Traditional | 08/08/2014SE |
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| K121027 | Diamond Calibrator Low, Diamond Calibrator HighJIT · Traditional | 12/20/2012SE |
| K121040 | Smartlyte Electrolyte AnalyzerCEM · Traditional | 08/30/2012SE |
| K121140 | Prolyte Electrolyte AnalyzerJGS · Traditional | 08/22/2012SE |
| K120591 | Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2JIT · Traditional | 04/17/2012SE |
| K103364 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual LevelJJY · Traditional | 05/06/2011SE |
| K102959 | Prolyte Electrolyte AnalyzerJGS · Traditional | 01/14/2011SE |
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Questions and answers
When was Prolyte Electrolyte Analyzer cleared by the FDA?
Prolyte Electrolyte Analyzer (K070104) received a 510(k) decision of Substantially Equivalent on May 7, 2008, 483 days after the submission was received.
What is the product code of K070104?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.