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Kemble Instruments, Inc.

United StatesFDA applicant, unverified

Devices
9

What Kemble Instruments, Inc. makes

Kemble Instruments, Inc. manufactures radioimmunoassay (RIA) gamma counters, including standalone units like the KEMTEK 400, KEMTEK 102, and KEMTEK 103, as well as specialized systems such as the THYRO-COUNT thyroid uptake probe. The company also provides accompanying software, including RIA software and the IMMU-COUNT system for automated radioisotope counting applications.

The company’s products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

  • Kemtek 400 Ria Gamma Counter Ref K832734

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

  • Kemtek 104 Ria Gamma Counter Ref K832736

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

  • Ria Software Ref K832760

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

  • Immu-Count Ref K820137

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

  • Thyro-Count Thyroid Uptake System 90IZD Probe Ref K827748

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

  • Kemtek 103 Ria Gamma Counter Ref K832735

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

  • Kemtek 102 Ref K830751

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

  • Kemble 405 Ref K842894

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

  • Immu-Count 404 Ref K822293

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

Frequently asked questions

How many devices does Kemble Instruments, Inc. have in the registry?

The registry currently lists 9 devices for Kemble Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kemble Instruments, Inc.'s devices?

Among its 9 most recently registered devices, Kemble Instruments, Inc. has devices listed in FDA 510(k) (9 devices).

What risk classes do Kemble Instruments, Inc.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Kemble Instruments, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Kemble Instruments, Inc. in the registry?

The most recently registered devices listed for Kemble Instruments, Inc. include KEMTEK 400 RIA GAMMA COUNTER, KEMTEK 104 RIA GAMMA COUNTER, RIA SOFTWARE and IMMU-COUNT.

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