HemosIL Factor XII Deficient Plasma

Plasma, Coagulation Factor Deficient

Instrumentation Laboratory Co.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Factor Xii Deficient Plasma.

Pre-market Notification Details

Device IDK180486
510k NumberK180486
Device Name:HemosIL Factor XII Deficient Plasma
ClassificationPlasma, Coagulation Factor Deficient
Applicant Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
Product CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-23
Decision Date2018-03-22
Summary:summary

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