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Gelman Sciences, Inc.

United StatesFDA applicant, unverified

Devices
31

What Gelman Sciences, Inc. makes

Gelman Sciences, Inc. manufactures laboratory filtration systems, including large-volume transfer filters and disposable membrane filters like ACRODISC and ACRO PACK, as well as vacuum-sealed filter units such as VACUSHIELD. The company also produces reagent sets for biochemical assays, such as electrophoresis reagent kits for HDL and CK-isozymes, alongside automated densitometers like the GLEMAN ACD-2020 for analyzing electrophoresis results. Drug dispensing spikes and pre-packaged drug standard sets are part of its portfolio, along with high-resolution electrophoresis systems including HI-PHORE and AUTOPHOR 128.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with many cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

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

Catalogue31

Newest first, rows 1-31 of 31

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  • Gleman Acd-2020 Automatic Computing Densitometer Ref K850260

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

  • Drug Standard Set Ref K884177

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

  • Pharmassure Large Volume Transfer Filters Ref K943127

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

  • Electrophoresis Reagent Set, Hdl Ref K790791

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

  • Hi-Phore High Resolution Electrophores Ref K821303

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

  • Autophor 128 Ref K810047

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

  • Acrodisc Ref K810829

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

  • Drug Dispensing Spike Ref K946190

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

  • Acro Pack Ref K822121

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

  • Vacushield Tm Ref K813159

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

  • Ck-Isozyme U.V. Reagent Set Ref K823550

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

  • Gelman Triphor Control Ref K850202

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

  • Vial Vent Filter Ref K942275

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

  • Optiphor-10 Ref K842560

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

  • Drug Reconstitution Filter Device Ref K941020

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

  • Syringe Filter Devices Ref K941589

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

  • Pre-Bypass Filter Ref K812539

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

  • Gelman Ig-Fix Kit Ref K812253

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

  • Hipp Buffer(Non-Barbital), P/N Ref K801378

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

  • Gelman Glyco-Phore Buffer Ref K820518

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

  • Gelman Electrophoresis Control Ref K811100

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

  • Gelman Lipoprotein Frs Set. P/N 51213 Ref K791606

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

  • Acrodisc Filter Assembly Ref K802765

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

  • Opticlear Ref K842485

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

  • Gelman Arterial Filter (43, 33 And 21 Micron) Ref K862068

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

  • Giardia Guard Ref K842052

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

  • Drug Control Set Ref K884178

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

  • Transducer Protector Ref K910821

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

  • Modified Gelman Arterial Filter Ref K892387

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

  • Automated Electrophoreses Machine Ref K791111

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

  • Chromatography Kit Ref K884176

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

Rows 1-31 of 31

Frequently asked questions

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

The registry currently lists 31 devices for Gelman Sciences, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gelman Sciences, Inc.'s devices?

Among its 31 most recently registered devices, Gelman Sciences, Inc. has devices listed in FDA 510(k) (31 devices).

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

Among its 31 most recently registered devices, the classes recorded for Gelman Sciences, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Gelman Sciences, Inc. include GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER, DRUG STANDARD SET, PHARMASSURE LARGE VOLUME TRANSFER FILTERS and ELECTROPHORESIS REAGENT SET, HDL.

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