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Esa Biosciences, Inc.

United StatesFDA applicant, unverified

Devices
2
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Esa Biosciences, Inc. makes

Esa Biosciences, Inc. manufactures analytical laboratory instruments for measuring vitamin D levels using high-performance liquid chromatography (HPLC) and blood lead testing systems, such as the LeadCare II. These devices are designed for clinical and research settings to quantify vitamin D metabolites and assess lead exposure in patient samples.

The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

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

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls3

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

FDA recall records list 3 recalls initiated by Esa Biosciences, Inc., the earliest on 2005-05-19 and the most recent on 2007-09-20. By recorded status: 3 terminated. The reasons filed fall into these groups: other reasons as filed. 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.

  • 2007

    • 20 Sep 2007 Z-0042-2008 Unclassified (pre-2012) Terminated Level 1 and Level 2 Control values were incorrectly assigned. Distribution: Nationwide and United Kingdom. Submission number: K052549
    • 20 Sep 2007 Z-0043-2008 Unclassified (pre-2012) Terminated Level 1 and Level 2 Control values were incorrectly assigned. Distribution: Nationwide and United Kingdom. Submission number: K052549

  • 2005

    • 19 May 2005 Z-0914-05 Unclassified (pre-2012) Terminated Lead test results may be reported lower than the actual value Distribution: United States Foreign: Mexico, Canada, Indonesia, Palestine, Kingdom of Saudi Arabia, Columbia, Switzerland, Romania,…
      Full distribution text United States Foreign: Mexico, Canada, Indonesia, Palestine, Kingdom of Saudi Arabia, Columbia, Switzerland, Romania, West Indies, Italy, Japan, Turkey, United Kingdom, Phillipines, Singapore, Jamaica, Uraguay, South Korea, Peru, Tanzia, South Africa, Quatar, Croatia, Zambia, China, Germany
      Submission number: K971640

Frequently asked questions

How many devices does Esa Biosciences, Inc. have in the registry?

The registry currently lists 2 devices for Esa Biosciences, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Esa Biosciences, Inc.'s devices?

Among its 2 most recently registered devices, Esa Biosciences, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Esa Biosciences, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Esa Biosciences, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Esa Biosciences, Inc.?

FDA recall records list 3 recalls initiated by Esa Biosciences, Inc., the most recent initiated on 2007-09-20. 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 Esa Biosciences, Inc. in the registry?

The most recently registered devices listed for Esa Biosciences, Inc. include ESA BIOSCIENCES INC. VITAMIN D HPLC TEST and LEADCARE II BLOOD LEAD TESTING SYSTEM.

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