K071239 is an FDA 510(k) clearance for the TOTAL PROTEIN URINE/CSF GEN.3. This device is classified as a Turbidimetric, Total Protein (Class II - Special Controls, product code JGQ).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 14, 2007, 134 days after receiving the submission on May 3, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1635.
| 510(k) Number | K071239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2007 |
| Decision Date | September 14, 2007 |
| Days to Decision | 134 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JGQ — Turbidimetric, Total Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1635 |