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Geometric Data, Div. Smithkline Corp.

United StatesFDA applicant, unverified

Devices
18

What Geometric Data, Div. Smithkline Corp. makes

Geometric Data manufactures laboratory reagents and instruments for hematological analysis, including HEMASTAIN stains (e.g., Wright stain, retic stain, phosphate buffer), fixatives, and blood-smearing tools like the MINIPREP blood-smearing instrument. Their portfolio also includes the HEMATRAK series—manual and automated devices for red blood cell morphology assessment, maturity profiling, and platelet counting—along with accessories like slide recaps.

The company’s products are regulated under FDA’s 510(k) premarket notification process, with devices classified as Class I (general controls) and Class II (special controls). These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer operates as a division of Smithkline Corp. and is based in the United States.

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

Catalogue18

Newest first, rows 1-18 of 18

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  • Hemastain Wright Stain Ref K760486

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

  • Hemastain Fixative Ref K760485

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

  • Blood-Smearing Instrument (Miniprep Tm) Ref K760007

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

  • Hematrak Model 480 Ref K790816

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

  • Hematrak Ref K770680

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

  • Hematrak Rbc Morphology Ref K761207

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

  • Hematrak Model 125 Ref K770701

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

  • Stain, Hemastain Retic Ref K790042

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

  • Platelets/Cu Mm Ref K780577

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

  • Hemastain Phosphate Buffer Ref K760487

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

  • Re-Cell Slide Recap Ref K772139

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

  • Hematrak Maturity Profile Option Ref K761208

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

  • Autolyzer 800 Ref K841852

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

  • Atypia Profile Monitor Ref K770550

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

  • Context Filter Ref K791108

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

  • Hematrak Abnormal Recognition Ref K791041

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

  • Atypical Lymphocyte & Ncb Classification Ref K770869

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

  • Hemaspinner Ref K811534

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

Rows 1-18 of 18

Frequently asked questions

How many devices does Geometric Data, Div. Smithkline Corp. have in the registry?

The registry currently lists 18 devices for Geometric Data, Div. Smithkline Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Geometric Data, Div. Smithkline Corp.'s devices?

Among its 18 most recently registered devices, Geometric Data, Div. Smithkline Corp. has devices listed in FDA 510(k) (18 devices).

What risk classes do Geometric Data, Div. Smithkline Corp.'s devices fall under?

Among its 18 most recently registered devices, the classes recorded for Geometric Data, Div. Smithkline Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Geometric Data, Div. Smithkline Corp. in the registry?

The most recently registered devices listed for Geometric Data, Div. Smithkline Corp. include HEMASTAIN WRIGHT STAIN, HEMASTAIN FIXATIVE, BLOOD-SMEARING INSTRUMENT (MINIPREP TM) and HEMATRAK MODEL 480.

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