K801061 is an FDA 510(k) clearance for the TOTAL PROTEIN TEST. This device is classified as a Biuret (colorimetric), Total Protein (Class II - Special Controls, product code CEK).
Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980, 76 days after receiving the submission on May 6, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1635.
| 510(k) Number | K801061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1980 |
| Decision Date | July 21, 1980 |
| Days to Decision | 76 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 |