X100 With Full Field Peripheral Blood Smear (PBS) Application

Device, Automated Cell-locating

Scopio Labs LTD.

The following data is part of a premarket notification filed by Scopio Labs Ltd. with the FDA for X100 With Full Field Peripheral Blood Smear (pbs) Application.

Pre-market Notification Details

Device IDK201301
510k NumberK201301
Device Name:X100 With Full Field Peripheral Blood Smear (PBS) Application
ClassificationDevice, Automated Cell-locating
Applicant Scopio Labs LTD. 11 Tiomkin St., 2nd Floor Tel Aviv,  IL 6578313
ContactShahar Karny
CorrespondentYarmela Pavlovic
Manatt Health 1 Embarcadero Center, 30th Floor San Francisco,  CA  94111
Product CodeJOY  
CFR Regulation Number864.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-15
Decision Date2020-10-02

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