Somas Chloride Assay Kit
FDA 510(k) K833787 · Somas Medical Industries, Inc.
510(k) numberK833787
Submission
- Device name
- Somas Chloride Assay Kit
- Applicant
- Somas Medical Industries, Inc.
Mchenry, IL, US - Received
- October 31, 1983
- Decision date
- January 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Somas Medical Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862179 | Somas Liquid Urine ControlJJY · Traditional | 07/01/1986SE |
| 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 |
Questions and answers
When was Somas Chloride Assay Kit cleared by the FDA?
Somas Chloride Assay Kit (K833787) received a 510(k) decision of Substantially Equivalent on January 11, 1984, 72 days after the submission was received.