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Biovation, Inc.

United StatesFDA applicant, unverified

Devices
11

What Biovation, Inc. makes

Biovation, Inc. manufactures laboratory information systems and hematology/urinalysis devices, including digital urinometers, nephelometers for antibiotic testing, chemistry consoles, and differential counting boards. Their portfolio also includes standalone data management systems for hematology and modular laboratory information systems like the LYRIS series. These tools support automated reporting, sample analysis, and integration with lab workflows.

The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II. Their systems are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Biovation, Inc. is based in the United States.

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

Catalogue11

Newest first, rows 1-11 of 11

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  • Hematology Data Management Sys Ref K821534

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

  • Biovation Urinalysis Reporter Ref K812604

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

  • Chemistry Console Ref K842401

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

  • Antibiotic Nephelometer Ref K781644

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

  • Biovation Digital Urinometer Ref K790862

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

  • Differential Counting Board Ref K915071

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

  • Lyris Modular Info System Ref K831830

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

  • Lyris 100/120 Laboratory Information System Ref K923844

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

  • Biovation Max Data Management System Ref K853026

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

  • Biovation K-Manager Ref K925528

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

  • Biovation Nephelometer Ref K792045

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

Rows 1-11 of 11

Frequently asked questions

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

The registry currently lists 11 devices for Biovation, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biovation, Inc.'s devices?

Among its 11 most recently registered devices, Biovation, Inc. has devices listed in FDA 510(k) (11 devices).

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

Among its 11 most recently registered devices, the classes recorded for Biovation, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Biovation, Inc. include HEMATOLOGY DATA MANAGEMENT SYS, BIOVATION URINALYSIS REPORTER, CHEMISTRY CONSOLE and ANTIBIOTIC NEPHELOMETER.

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