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Colony Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
16

What Colony Laboratories, Inc. makes

Colony Laboratories, Inc. manufactures calibrator and assay kits for therapeutic drug monitoring, including digoxin, theophylline, phenytoin, phenobarbital, carbamazepine, gentamicin, amikacin, and tobramycin. These products are designed for use in clinical laboratories to measure drug concentrations in patient samples, supporting precision in medication management.

The company’s portfolio is regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. Products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

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  • Fpr Digoxin Calibrator Kit Ref K894522

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

  • Fpr Gentamicin Calibrator Kit Ref K894524

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

  • Fpr Digoxin Kit Ref K894521

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

  • Fpr Theophylline Kit Ref K894529

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

  • Fpr Theophylline Calibrator Kit Ref K894530

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

  • Fpr Amikacin Calibrator Kit Ref K894518

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

  • Fpr Carbamazepine Kit Ref K894519

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

  • Fpr Tobramycin Calibrator Kit Ref K894532

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

  • Fpr Phenobarbital Calibrator Kit Ref K894526

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

  • Fpr Phenobarbital Kit Ref K894525

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

  • Fpr Carbamazepine Calibrator Kit Ref K894520

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

  • Fpr Phenytoin Calibrator Kit Ref K894528

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

  • Fpr Gentamicin Kit Ref K894523

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

  • Fpr Amikacin Kit Ref K894517

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

  • Fpr Phenytoin Kit Ref K894527

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

  • Fpr Tobramycin Kit Ref K894531

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

Rows 1-16 of 16

Frequently asked questions

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

The registry currently lists 16 devices for Colony Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Colony Laboratories, Inc.'s devices?

Among its 16 most recently registered devices, Colony Laboratories, Inc. has devices listed in FDA 510(k) (16 devices).

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

Among its 16 most recently registered devices, the classes recorded for Colony Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Colony Laboratories, Inc. include FPR DIGOXIN CALIBRATOR KIT, FPR GENTAMICIN CALIBRATOR KIT, FPR DIGOXIN KIT and FPR THEOPHYLLINE KIT.

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