DIACROM * FACTOR X KIT HA31

Test, Qualitative And Quantitative Factor Deficiency

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Diacrom * Factor X Kit Ha31.

Pre-market Notification Details

Device IDK832372
510k NumberK832372
Device Name:DIACROM * FACTOR X KIT HA31
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant WELLCOME DIAGNOSTICS 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 Received1983-07-18
Decision Date1983-09-29

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