Randox Liquid Immunoassay Premium Controls, Level 1, LEVEL2, Level 3 and Tri Level
FDA 510(k) K112337 · Randox Laboratories, Ltd.
510(k) numberK112337
Submission
- Device name
- Randox Liquid Immunoassay Premium Controls, Level 1, LEVEL2, Level 3 and Tri Level
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- August 15, 2011
- Decision date
- December 1, 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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| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| 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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Questions and answers
When was Randox Liquid Immunoassay Premium Controls, Level 1, LEVEL2, Level 3 and Tri Level cleared by the FDA?
Randox Liquid Immunoassay Premium Controls, Level 1, LEVEL2, Level 3 and Tri Level (K112337) received a 510(k) decision of Substantially Equivalent on December 1, 2011, 108 days after the submission was received.
What is the product code of K112337?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.