HEMOSIL PROS

Test, Qualitative And Quantitative Factor Deficiency

INSTRUMENTATION LABORATORY CO.

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

Pre-market Notification Details

Device IDK053499
510k NumberK053499
Device Name:HEMOSIL PROS
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg,  NY  10962
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg,  NY  10962
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-16
Decision Date2006-01-13
Summary:summary

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