K141925 is an FDA 510(k) clearance for the TOTAL PROTEIN URINE/CSF GEN.3. This device is classified as a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I - General Controls, product code JIQ).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on December 9, 2014, 146 days after receiving the submission on July 16, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1645.
| 510(k) Number | K141925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2014 |
| Decision Date | December 09, 2014 |
| Days to Decision | 146 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIQ — Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1645 |