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 |