XN CHECK BF

Mixture, Hematology Quality Control

Streck

The following data is part of a premarket notification filed by Streck with the FDA for Xn Check Bf.

Pre-market Notification Details

Device IDK120744
510k NumberK120744
Device Name:XN CHECK BF
ClassificationMixture, Hematology Quality Control
Applicant Streck 7002 SOUTH 109TH ST. Omaha,  NE  68128
ContactDeborah S Kipp
CorrespondentDeborah S Kipp
Streck 7002 SOUTH 109TH ST. Omaha,  NE  68128
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-12
Decision Date2012-10-19
Summary:summary

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