Somas Liquid Urine Control
FDA 510(k) K862179 · Somas Medical Industries, Inc.
510(k) numberK862179
Submission
- Device name
- Somas Liquid Urine Control
- Applicant
- Somas Medical Industries, Inc.
Santa Ana, CA, US - Received
- June 9, 1986
- Decision date
- July 1, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| 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 |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K842134 | Somas Coomasie Blue Total Protein AssayJGQ · Traditional | 07/06/1984SE |
| K840486 | Total Bilirubin ReagentCIG · Traditional | 04/25/1984SE |
| K840974 | Somas Human Spinal Fluid ControlDFI · Traditional | 04/05/1984SE |
| K840485 | Total Iron Uibc/Tibc AssayCFM · Traditional | 03/12/1984SE |
| K833787 | Somas Chloride Assay Kit · Traditional | 01/11/1984SE |
Questions and answers
When was Somas Liquid Urine Control cleared by the FDA?
Somas Liquid Urine Control (K862179) received a 510(k) decision of Substantially Equivalent on July 1, 1986, 22 days after the submission was received.
What is the product code of K862179?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.