HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

Plasma, Coagulation Control

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Low Abnormal Controlled (assayed); Hemosil Low Abnormal Control 2 (unassayed).

Pre-market Notification Details

Device IDK021022
510k NumberK021022
Device Name:HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
ClassificationPlasma, Coagulation Control
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeGGN  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-29
Decision Date2002-05-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950078982 K021022 000
08426950660668 K021022 000

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