K842134 is an FDA 510(k) clearance for the SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY. This device is classified as a Turbidimetric, Total Protein (Class II - Special Controls, product code JGQ).
Submitted by Somas Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984, 37 days after receiving the submission on May 30, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1635.
| 510(k) Number | K842134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1984 |
| Decision Date | July 06, 1984 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGQ — Turbidimetric, Total Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1635 |