Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level
FDA 510(k) K103364 · Diamond Diagnostics, Inc.
510(k) numberK103364
Submission
- Device name
- Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level
- Applicant
- Diamond Diagnostics, Inc.
Holliston, MA, US - Received
- November 16, 2010
- Decision date
- May 6, 2011
- 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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| 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 |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
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| 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 |
| 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 |
| K093492 | Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical CalibratorJJY · Traditional | 03/19/2010SE |
Questions and answers
When was Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level cleared by the FDA?
Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level (K103364) received a 510(k) decision of Substantially Equivalent on May 6, 2011, 171 days after the submission was received.
What is the product code of K103364?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.