XN CAL PF

Calibrator For Cell Indices

Streck

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

Pre-market Notification Details

Device IDK120747
510k NumberK120747
Device Name:XN CAL PF
ClassificationCalibrator For Cell Indices
Applicant Streck 7002 SOUTH 109TH ST. Omaha,  NE  68128
ContactDeborah S Kipp
CorrespondentDeborah S Kipp
Streck 7002 SOUTH 109TH ST. Omaha,  NE  68128
Product CodeKRX  
CFR Regulation Number864.8150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-12
Decision Date2012-10-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.