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The assigned 5 10(k) number - accessdata fda

The assigned 5 10(k) number - accessdata fda 2025

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The document is a 510(k) summary submitted by Hitachi Chemical Diagnostics for the Hitachi Clinical Analyzer S TEST Reagent Cartridges, which are designed for the quantitative measurement of cholesterol (CHO), HDL, LDL, and triglycerides (TG) in serum or heparinized plasma. It outlines the device's intended use, technological characteristics, nonclinical and clinical testing results, and regulatory compliance. The analyzer is intended for use in clinical laboratories or physician office laboratories and has been determined to be substantially equivalent to predicate devices.

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How do I find my FDA product code?

The easiest way to determine the product code is to become familiar with the product itself, including the label, the processing information, intended use of product, the container type, who will use or consume the product, etc.

What is FDA 510 K summaries?

Overview of Section 510(k) Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is a FDA 510K number?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act) that is not subject to premarket approval. Learn more Search Database. Help Download Files. 510K

What is the difference between traditional 510K and special 510K?

The difference between the three types of 510(k) submissions comes down to how you prove substantial equivalence: Traditional 510(k): Prove substantial equivalence to a legally marketed predicate device. Special 510(k): Prove substantial equivalence to your own previously cleared device.

What are the different types of 510K applications?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are the three types of 510K?

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements.

How do I find my FDA approved devices?

Go to the Devices@FDA Database. In the Enter a search term in the space below field, type the name of the device or the company name. You can type the exact name of a specific device or a generic name for a category of devices (such as pacemaker). Click Search.

The assigned 5 10(k) number - accessdata fda 2025

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