Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014345398

FEI Number

3014345398

Entity Name

DELCON SRL

City/State/Country

Grassobbio Bergamo, IT

Establishment Address

Via Zanica 19/F/I, Grassobbio Bergamo 24050, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Delcon Srl (Owner Number: 10057182)

Owner / Operator Contact Address

Via Zanica 19/F/I, Grassobbio, IT-BG 24050, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK180229

PMA Number

N/A

All Registered Proprietary Names

GIO.MZ.WIFI.P2 - GIOTTO MONZA, Automatic blood components extractor. Double press. Wi-Fi version HMIX4.42 Milano Basic version (Gulf Coast) HMIX42 Milano Standard version (white/gray) HMIX41 Milano RFID version (white/gray) HMIX4.32 Milano standard version (Versiti) HMIX4.21 Milano RFID version (white/red) HMIX4.22 Milano Standard version (white/red) HMIX4.31 Milano RFID version (Versiti) HMIX4.41 Milano RFID version (Gulf Coast) HMIX3.WIFI.RFID Blood collection monitor (Version with WiFi and integrated RFID options installed) HMIX3.LAN.RFID Blood collection monitor (Version with LAn and integrated RFID oprions installed) HMIX3.485 Blood collection monitor (Basic version) HMIX3.WIFI Blood collection monitor (Version with WiFi option installed) HMIX3.485.RFID Blood collection monitor (Version with internal RFID option installed) HMIX3.LAN Blood collection monitor (Version with LAN option installed)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2018-05-14
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2025-04-10
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2019-06-11
MYJ	Device, Mixing And Weighing, Semi-Automated	Hematology	Class 2	864.9195	2020-02-26
MYJ	Device, Mixing And Weighing, Semi-Automated	Hematology	Class 2	864.9195	2018-11-27

Official Correspondent

Barbara Sala

US Agent Details

Lorenzo Da Madice Business: ISOPLAN USA Email: isoplan@fda-510k.com Phone: (386) 8680618

Related Public Records

Same Entity

Delcon Srl

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014345398. Last updated year: 2026. Please use registration number 3014345398 when referencing this establishment in official correspondence.