K863301 is an FDA 510(k) clearance for the DEMAND TOTAL PROTEIN. This device is classified as a Biuret (colorimetric), Total Protein (Class II - Special Controls, product code CEK).
Submitted by Cooper Biomedical, Inc. (Malvern, US). The FDA issued a Cleared decision on September 26, 1986, 32 days after receiving the submission on August 25, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1635.
| 510(k) Number | K863301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1986 |
| Decision Date | September 26, 1986 |
| Days to Decision | 32 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 |