FACTOR DEFICIENT PLASMAS - FACTOR IX (9)

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 Factor Deficient Plasmas - Factor Ix (9).

Pre-market Notification Details

Device IDK972288
510k NumberK972288
Device Name:FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
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 Received1997-06-19
Decision Date1997-07-14

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