X-CAL

Calibrator For Cell Indices

Streck

The following data is part of a premarket notification filed by Streck with the FDA for X-cal.

Pre-market Notification Details

Device IDK083200
510k NumberK083200
Device Name:X-CAL
ClassificationCalibrator For Cell Indices
Applicant Streck 7002 SOUTH 109TH ST. Omaha,  NE  68128
ContactErin Johnson
CorrespondentErin Johnson
Streck 7002 SOUTH 109TH ST. Omaha,  NE  68128
Product CodeKRX  
CFR Regulation Number864.8150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-30
Decision Date2009-02-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14987562460592 K083200 000
14987562460585 K083200 000

Trademark Results [X-CAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
X-CAL
X-CAL
85532359 4905311 Live/Registered
Masimo Corporation
2012-02-02
X-CAL
X-CAL
77143187 3397442 Live/Registered
DOUBLE BLACK IMAGING CORPORATION
2007-03-28
X-CAL
X-CAL
74386043 1861656 Dead/Cancelled
MELIUS S.A.
1993-05-04

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