Atellica Hema 580 Analyzer K232946 — Device overview

The K Number is a unique identifier assigned by the FDA for tracking medical devices. The Regulation Number references the specific FDA regulation that governs the device, confirming its registration and compliance with FDA standards for easy regulatory verification.

The Manufacturer Information section includes details about the primary manufacturer of the device, including their name and location. If applicable, it also lists the US Agent responsible for representing the manufacturer in the United States. The agent’s contact information, such as email and phone number, is provided for further communication. Additionally, the Registration Addresses section shows where the manufacturer is located worldwide and includes information about their registration status and validity, such as the Expiry Year of their registration and the establishment type (e.g., manufacturing medical devices).

The Owner/Operator Information section provides details about the company or entity responsible for the device. It typically includes the company name of the device's owner or operator, as well as the business address, which is the primary location where the business operates or is registered. This information helps identify the entity managing or manufacturing the device and provides transparency regarding the responsible party for regulatory purposes.