HELENA FACTOR X DEFICIENT SUBSTRATE

Test, Qualitative And Quantitative Factor Deficiency

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Helena Factor X Deficient Substrate.

Pre-market Notification Details

Device IDK792508
510k NumberK792508
Device Name:HELENA FACTOR X DEFICIENT SUBSTRATE
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant HELENA LABORATORIES 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 Received1979-12-04
Decision Date1979-12-31

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