UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA

Test, Qualitative And Quantitative Factor Deficiency

UNIVERSAL REAGENTS, INC.

The following data is part of a premarket notification filed by Universal Reagents, Inc. with the FDA for Universal Reagent Factor V Deficient Plasma.

Pre-market Notification Details

Device IDK964270
510k NumberK964270
Device Name:UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant UNIVERSAL REAGENTS, INC. 2858 N. PENNSYLVANIA ST. Indianapolis,  IN  46205
ContactJorge Miller
CorrespondentJorge Miller
UNIVERSAL REAGENTS, INC. 2858 N. PENNSYLVANIA ST. Indianapolis,  IN  46205
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-25
Decision Date1996-12-18
Summary:summary

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