FDA.reportPublic FDA data

SCOPIO LABS LTD.

Matched from indexed company URL: SCOPIO LABS LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30181828323018182832SCOPIO LABS LTD.1N2026-01-0110 Hasharon St. Tel Aviv IL 6618502

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2879441168733015K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationJOY2025-06-27
2879441803848227K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationJOY2022-05-03
2879441323529901K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationJOY2020-10-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOY32025-06-27

PMN#

GUDID#