PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS

Calibrators, Drug Specific

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Preciset Dat Thc And Preciset Dat Thc 20 Calibrators.

Pre-market Notification Details

Device IDK033246
510k NumberK033246
Device Name:PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
ClassificationCalibrators, Drug Specific
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
ContactKerwin Kaufman
CorrespondentKerwin Kaufman
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-07
Decision Date2003-12-02
Summary:summary

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