Somas Coomasie Blue Total Protein Assay
FDA 510(k) K842134 · Somas Medical Industries, Inc.
510(k) numberK842134
Submission
- Device name
- Somas Coomasie Blue Total Protein Assay
- Applicant
- Somas Medical Industries, Inc.
Mchenry, IL, US - Received
- May 30, 1984
- Decision date
- July 6, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGQ – Turbidimetric, Total Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1635
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131051 | Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)JGQ · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K072638 | Roche/Hitachi Urinary/Csf Protein with Model(S) Cat #11877801JGQ · Special | Roche Diagnostics Corp. | 10/19/2007SE |
| K071239 | Total Protein Urine/Csf GEN.3JGQ · Special | Roche Diagnostics | 09/14/2007SE |
| K981295 | UproJGQ · Traditional | Abbott Laboratories | 10/01/1998SE |
| K981682 | UproJGQ · Traditional | Abbott Laboratories | 09/21/1998SE |
| K925794 | Trace Microprotein ReagentJGQ · Traditional | Trace America, Inc. | 03/29/1993SE |
| K913615 | Urinary/Csf ProteinJGQ · Traditional | Boehringer Mannheim Corp. | 09/13/1991SE |
| K903914 | Paramax Cerebrospinal Fluid/Urine Protein BlankJGQ · Traditional | Baxter Healthcare Corp | 10/03/1990SE |
| K901083 | Emds(Tm) Cerebrospinal Fluid Protein, #67668/95JGQ · Traditional | Em Diagnostic Systems, Inc. | 04/16/1990SE |
| K863478 | Cerebrospinal Fluid Protein Testpack, #67668/95JGQ · Traditional | Em Diagnostic Systems, Inc. | 10/29/1986SE |
More from Em Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862179 | Somas Liquid Urine ControlJJY · Traditional | 07/01/1986SE |
| 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 Coomasie Blue Total Protein Assay cleared by the FDA?
Somas Coomasie Blue Total Protein Assay (K842134) received a 510(k) decision of Substantially Equivalent on July 6, 1984, 37 days after the submission was received.
What is the product code of K842134?
The FDA product code is JGQ – Turbidimetric, Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.