FACTOR DEFICIENT SUBSTRATE PLASMA II

Test, Qualitative And Quantitative Factor Deficiency

DIATECH, INC.

The following data is part of a premarket notification filed by Diatech, Inc. with the FDA for Factor Deficient Substrate Plasma Ii.

Pre-market Notification Details

Device IDK840927
510k NumberK840927
Device Name:FACTOR DEFICIENT SUBSTRATE PLASMA II
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant DIATECH, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-02
Decision Date1984-04-30

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