HEMOCUE HEMOLIN

Control, Hemoglobin

DIRECT SOLUTIONS

The following data is part of a premarket notification filed by Direct Solutions with the FDA for Hemocue Hemolin.

Pre-market Notification Details

Device IDK963908
510k NumberK963908
Device Name:HEMOCUE HEMOLIN
ClassificationControl, Hemoglobin
Applicant DIRECT SOLUTIONS 7 HAYRICK LN. P.O. BOX 900 Westford,  MA  01886
ContactBill Donohue
CorrespondentBill Donohue
DIRECT SOLUTIONS 7 HAYRICK LN. P.O. BOX 900 Westford,  MA  01886
Product CodeGGM  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-30
Decision Date1996-10-16
Summary:summary

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