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Bio-Tek Instruments, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
37
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Bio-Tek Instruments, Inc. makes

Bio-Tek Instruments, Inc. makes automated microplate readers such as the ELX808, ELX800, EL800, and EL310 models, as well as specialized instruments including the Bio-Tek UW-II, Ceres 900C and Ceres UV900C, Bio-Tek Chromoscan, and IDA-4 and IPT-MC systems. The company also produces an ear oximeter, a contourograph M-500, a Gould Xcaliber, and a defibrillator analyzer model QED-5.

The devices in the portfolio are classified as Class I, Class II, and unclassified (U) and are listed in the FDA 510(k) registry. The company is based in the United States.

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

Catalogue37

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Rows 1-37 of 37

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Bio-Tek Instruments, Inc., initiated on 2009-03-12. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware 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.

  • 2009

    • 12 Mar 2009 Z-2223-2009 Unclassified (pre-2012) Terminated Software design allowed false negatives to be read when wells are dark. Distribution: Worldwide Distribution -- United States (MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX) and Peru.

Frequently asked questions

How many devices does Bio-Tek Instruments, Inc. have in the registry?

The registry currently lists 37 devices for Bio-Tek Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bio-Tek Instruments, Inc.'s devices?

Among its 37 most recently registered devices, Bio-Tek Instruments, Inc. has devices listed in FDA 510(k) (37 devices).

What risk classes do Bio-Tek Instruments, Inc.'s devices fall under?

Among its 37 most recently registered devices, the classes recorded for Bio-Tek Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Bio-Tek Instruments, Inc.?

FDA recall records list 1 recall initiated by Bio-Tek Instruments, Inc., the most recent initiated on 2009-03-12. 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 Bio-Tek Instruments, Inc. in the registry?

The most recently registered devices listed for Bio-Tek Instruments, Inc. include IDA-4 AND IPT-MC, THE BIO-TEK UW-II, ELX808 AUTOMATED MICROPLATE READERS and EAR OXIMETER.

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