HEMOSIL HOMOCYSTEINE AND CONTROLS

Urinary Homocystine (nonquantitative) Test System

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Homocysteine And Controls.

Pre-market Notification Details

Device IDK061598
510k NumberK061598
Device Name:HEMOSIL HOMOCYSTEINE AND CONTROLS
ClassificationUrinary Homocystine (nonquantitative) Test System
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeLPS  
CFR Regulation Number862.1377 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-08
Decision Date2006-09-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950453031 K061598 000
08426950453024 K061598 000

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