HEMOSIL FACTOR IX 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 Ix Deficient Plasma.

Pre-market Notification Details

Device IDK031829
510k NumberK031829
Device Name:HEMOSIL FACTOR IX DEFICIENT PLASMA
ClassificationPlasma, Coagulation Factor Deficient
Applicant INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg,  NY  10962
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg,  NY  10962
Product CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-13
Decision Date2003-07-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950478553 K031829 000

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