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Gibson Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
4
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Gibson Laboratories, Inc. makes

Gibson Laboratories, Inc. manufactures microbiological media and diagnostic test kits, including the GIBSON ID-M for microbial identification, SAF Fixative for specimen preparation, the GIBSON ID A.E. Test for antimicrobial susceptibility, and P and T Medium for pathogen detection.

These products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Gibson Id-M. Cat. Ref K955826

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

  • Saf Fixative Ref K905120

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

  • Gibson Id A.E. Test Ref K953247

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

  • P And T Medium Ref K904773

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

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 3 recalls initiated by Gibson Laboratories, Inc., the earliest on 2009-12-17 and the most recent on 2017-01-20. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

2 initiated before 2017

  • 2017

    • 20 Jan 2017 Z-0606-2018 Class II Terminated The firm information that the product was reporting false positive results Distribution: Distributed to the states of AL, AZ & MS.

  • 2009

    • 17 Dec 2009 Z-0827-2010 Unclassified (pre-2012) Terminated Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the statement for In Vitro Diagnostic Use. The product insert should have indicated for Research Use Only instead of for In Vitro Diagnostic Use. Distribution: Distribution of the product was limited to AL, FL, IL, KY, MA, MI, MO, NY, OH, PA, & VA and one customer in France.
    • 17 Dec 2009 Z-0828-2010 Unclassified (pre-2012) Terminated Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the statement for In Vitro Diagnostic Use. The product insert should have indicated for Research Use Only instead of for In Vitro Diagnostic Use. Distribution: Distribution of the product was limited to AL, FL, IL, KY, MA, MI, MO, NY, OH, PA, & VA and one customer in France.

Frequently asked questions

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

The registry currently lists 4 devices for Gibson Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

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

Among its 4 most recently registered devices, Gibson Laboratories, Inc. has devices listed in FDA 510(k) (4 devices).

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

Among its 4 most recently registered devices, the classes recorded for Gibson Laboratories, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Gibson Laboratories, Inc.?

FDA recall records list 3 recalls initiated by Gibson Laboratories, Inc., the most recent initiated on 20 Jan 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

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

The most recently registered devices listed for Gibson Laboratories, Inc. include GIBSON ID-M. CAT., SAF FIXATIVE, GIBSON ID A.E. TEST and P AND T MEDIUM.

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