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Wako Intl., Inc.

United StatesFDA applicant, unverified

Devices
4

What Wako Intl., Inc. makes

Wako Intl., Inc. manufactures diagnostic test kits including Urea Nitrogen Test, Cholesterol Test, and Glucose Test, as well as laboratory equipment such as the SERI-SEP Serum/Plasma Isolator.

The company's products are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Wako Intl., Inc. is based in the US.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Urea Nitrogen Test Ref K781899

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Seri-Sep Serum/Plasma Islolator Ref K781629

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Wako Cholesterol Test Ref K790768

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Glucose Test Ref K781342

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Wako Intl., Inc. have in the registry?

The registry currently lists 4 devices for Wako Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Wako Intl., Inc.'s devices?

Among its 4 most recently registered devices, Wako Intl., Inc. has devices listed in FDA 510(k) (4 devices).

What risk classes do Wako Intl., Inc.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Wako Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Wako Intl., Inc. in the registry?

The most recently registered devices listed for Wako Intl., Inc. include UREA NITROGEN TEST, SERI-SEP SERUM/PLASMA ISLOLATOR, WAKO CHOLESTEROL TEST and GLUCOSE TEST.

Generated automatically from registry data and not verified by a human reviewer.