XN CAL

Calibrator For Cell Indices

Streck

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

Pre-market Notification Details

Device IDK120745
510k NumberK120745
Device Name:XN CAL
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 Date2012-10-19
Summary:summary

Trademark Results [XN CAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XN CAL
XN CAL
85147651 4315467 Live/Registered
Sysmex Corporation
2010-10-07

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