K792346 is an FDA 510(k) clearance for the TWO MINUTE PROTEINTEST. This device is classified as a Biuret (colorimetric), Total Protein (Class II - Special Controls, product code CEK).
Submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 17 days after receiving the submission on November 19, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1635.
| 510(k) Number | K792346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1979 |
| Decision Date | December 06, 1979 |
| Days to Decision | 17 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 |