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ACTIVATOR

FDA 510(k)

Class II (US FDA 510(k))

510(k) K790346

by Tri-Med, Inc.

Identifiers

510(k) Number
K790346 FDA 510(k)
FDA Product Code
JBP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7140 FDA 510(k)
Regulation Number
864.7140 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ACTIVATOR is a medical device used for activated whole blood clotting time testing. It is designed to measure the time it takes for a blood sample to clot after activation, which is an important parameter in hematology testing.

The device is manufactured by Tri-Med, Inc. and is supplied as a single-use or reusable product depending on the specific model. It is not MRI compatible and should be stored according to the manufacturer's instructions. The ACTIVATOR has FDA 510(k) clearance with product code JBP and is classified as Class II medical device.

Frequently asked questions

What is the ACTIVATOR used for?

The ACTIVATOR is a medical device designed to measure the time it takes for a blood sample to clot after activation, which is an important parameter in hematology testing. This measurement helps clinicians assess blood coagulation function.

Is the ACTIVATOR single-use or reusable?

The ACTIVATOR is supplied as either a single-use or reusable product depending on the specific model selected. Users should refer to the specific model's instructions for proper usage and disposal guidelines.

What are the storage requirements for the ACTIVATOR?

The ACTIVATOR should be stored according to the manufacturer's instructions. The device is not MRI compatible, so it should be kept away from strong magnetic fields. Proper storage conditions help maintain the device's functionality and accuracy.

What regulatory approvals does the ACTIVATOR have?

The ACTIVATOR has FDA 510(k) clearance with product code JBP and is classified as a Class II medical device. It was determined to be substantially equivalent to predicate devices for activated whole blood clotting time testing.

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. Sources consulted: ACTIVATOR (K790346) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tri-Med, Inc.

Sources (1)

  • FDA 510(k) K790346 24 fields · synced Oct 1, 2026