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Denley Instruments, Inc.

United StatesFDA applicant, unverified

Devices
9

What Denley Instruments, Inc. makes

Denley Instruments, Inc. manufactures automated laboratory instruments for processing and analyzing samples in microplate and well-based formats. Their products include microplate reagent dispensers, well washing systems (such as the WellWash 2, 4, and 4 Mark II), sample processors (e.g., WellPrep 1 and WellPrep 2000), and plate readers (such as the Anthos 2001). These devices are designed for liquid handling, sample preparation, and optical detection in research and clinical diagnostics.

The company’s devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. These instruments are intended for use in the United States, where regulatory compliance is demonstrated through the FDA’s clearance process. The portfolio is not subject to additional EU MDR or other international regulatory schemes as listed.

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

Catalogue9

Newest first, rows 1-9 of 9

  • Denley Wellwash 2 And 4 Ref K894271

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

  • Wellprep 1 Ref K913567

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

  • Microplate Reagent Dispenser Ref K900599

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

  • Wellprep 2000 Sample Processor Ref K922183

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

  • Denley Anthos 2001 Reader Ref K894270

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

  • Denley Welldill 3 Ref K894272

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

  • Stacking Microplate Washer Ref K915284

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

  • Wellwash 4 Mark Ii Ref K922803

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

  • Denley Wellprep 2 Sample Processor Ref K922327

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

Frequently asked questions

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

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

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

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

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

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

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

The most recently registered devices listed for Denley Instruments, Inc. include DENLEY WELLWASH 2 AND 4, WELLPREP 1, MICROPLATE REAGENT DISPENSER and WELLPREP 2000 SAMPLE PROCESSOR.

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