K072638 is an FDA 510(k) clearance for the ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801. This device is classified as a Turbidimetric, Total Protein (Class II - Special Controls, product code JGQ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 19, 2007, 31 days after receiving the submission on September 18, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1635.
| 510(k) Number | K072638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2007 |
| Decision Date | October 19, 2007 |
| Days to Decision | 31 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 |