The following data is part of a premarket notification filed by Somas Medical Industries, Inc. with the FDA for Somas Coomasie Blue Total Protein Assay.
| Device ID | K842134 |
| 510k Number | K842134 |
| Device Name: | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY |
| Classification | Turbidimetric, Total Protein |
| Applicant | SOMAS MEDICAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JGQ |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-07-06 |