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Specialty Assayed CONTROL-2 Cat. No. 5302

FDA 510(k)

Class II (US FDA 510(k))

510(k) K941872

by Helena Laboratories

Identifiers

510(k) Number
K941872 FDA 510(k)
FDA Product Code
GGC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5425 FDA 510(k)
Regulation Number
864.5425 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Specialty Assayed Control-2 Cat. No. 5302 is a control device, specifically a plasma abnormal control. It is used in hematology applications.

The device is supplied by Helena Laboratories and has been found to be substantially equivalent. It is classified as a class 2 device and has the product code GGC. The device has been assigned the regulation number 864.5425 and has the FDA 510K authorization.

Frequently asked questions

What is the Specialty Assayed Control-2 used for?

The Specialty Assayed Control-2 is used in hematology applications as a plasma abnormal control device.

What is the regulatory classification of the device?

The device is classified as a class 2 device with the product code GGC and regulation number 864.5425.

Is the device substantially equivalent to other devices?

Yes, the device has been found to be substantially equivalent, as indicated by its FDA 510K authorization.

Who is the manufacturer of the Specialty Assayed Control-2?

The device is supplied by Helena Laboratories.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K941872 24 fields · synced Sep 23, 2026