FACTOR DEFICIENT PLASMAS - FACTOR XI (11)

Plasma, Coagulation Factor Deficient

UNIVERSAL REAGENTS, INC.

The following data is part of a premarket notification filed by Universal Reagents, Inc. with the FDA for Factor Deficient Plasmas - Factor Xi (11).

Pre-market Notification Details

Device IDK972286
510k NumberK972286
Device Name:FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
ClassificationPlasma, Coagulation Factor Deficient
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 CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-19
Decision Date1997-07-14
Summary:summary

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