ELECSYS CA 19-9 CALCHECK

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 Elecsys Ca 19-9 Calcheck.

Pre-market Notification Details

Device IDK051185
510k NumberK051185
Device Name:ELECSYS CA 19-9 CALCHECK
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
ContactCorina Harper
CorrespondentCorina Harper
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-09
Decision Date2005-07-06
Summary:summary

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