Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)
FDA 510(k) K093384 · Diamond Diagnostics, Inc.
510(k) numberK093384
Submission
- Device name
- Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)
- Applicant
- Diamond Diagnostics, Inc.
Holliston, MA, US - Received
- October 30, 2009
- Decision date
- March 10, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
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More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEM · Traditional | 10/01/2020SE |
| K133751 | Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsJIT · Traditional | 08/08/2014SE |
| K124009 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed…JJY · Traditional | 04/17/2013SE |
| 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 |
| K093357 | Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module…JIT · Traditional | 06/24/2010SE |
Questions and answers
When was Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3) cleared by the FDA?
Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3) (K093384) received a 510(k) decision of Substantially Equivalent on March 10, 2010, 131 days after the submission was received.
What is the product code of K093384?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.