
Roche Diagnostics Corp.
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PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS is an FDA 510(k)-cleared medical device (K040280) manufactured by Roche Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 10, 2004. Regulation: 8.