MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)

Multi-analyte Controls, All Kinds (assayed)

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To Roche Diagnostics Precinorm Proteins In Urine/csf (puc) And Precipath Proteins In Urine/csf (puc).

Pre-market Notification Details

Device IDK041812
510k NumberK041812
Device Name:MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
ContactTheresa M Ambrose
CorrespondentTheresa M Ambrose
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-06
Decision Date2004-07-27
Summary:summary

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