K971524 is an FDA 510(k) clearance for the TOTAL PROTEIN OR TP. This device is classified as a Biuret (colorimetric), Total Protein (Class II - Special Controls, product code CEK).
Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on May 16, 1997, 18 days after receiving the submission on April 28, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1635.
| 510(k) Number | K971524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1997 |
| Decision Date | May 16, 1997 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CEK — Biuret (colorimetric), Total Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1635 |