K905790 is an FDA 510(k) clearance for the TOTAL PROTEIN REAGENT SET. This device is classified as a Biuret (colorimetric), Total Protein (Class II - Special Controls, product code CEK).
Submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on February 21, 1991, 56 days after receiving the submission on December 27, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1635.
| 510(k) Number | K905790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1990 |
| Decision Date | February 21, 1991 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEK — Biuret (colorimetric), Total Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1635 |