MASSTRAK IMMUNOSUPPRESSANTS KIT

Enzyme Immunoassay, Tracrolimus

WATERS CORPORATION

The following data is part of a premarket notification filed by Waters Corporation with the FDA for Masstrak Immunosuppressants Kit.

Pre-market Notification Details

Device IDK063868
510k NumberK063868
Device Name:MASSTRAK IMMUNOSUPPRESSANTS KIT
ClassificationEnzyme Immunoassay, Tracrolimus
Applicant WATERS CORPORATION 163 CABOT STREET Beverly,  MA  01915
ContactFran White
CorrespondentFran White
WATERS CORPORATION 163 CABOT STREET Beverly,  MA  01915
Product CodeMLM  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1678 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-29
Decision Date2007-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816776020001 K063868 000

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