Leavitt Medical, Inc.

FDA Device Registration & Listing · Lehi, UT, US · Registration 3012104009

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012104009
FEI Number
3012104009
Entity Name
Leavitt Medical, Inc.
City/State/Country
Lehi, UT, US
Establishment Address
2889 W Ashton Blvd Ste 300, Lehi, UT 84048, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Leavitt Medical, Inc. (Owner Number: 10045889)
Owner / Operator Contact Address
2889 W Ashton Blvd Ste 300, Lehi, UT 84048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tissue holder, transport, fixation/preservation device - BxView Sectionable tissue holder suitable for processing, embedding, and microtomy - BxChip Sectionable fiducial for orienting tissue on a microscope slide - BxAlign Sectionable fiducial for specifying focal plane for digital slide scanning - Focal Ring

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IDZ Cassettes, Tissue Pathology Class 1 864.3010 2015-05-22
MJI Specimen/Tissue, Identification Orientation Pathology Class 1 864.3010 2014-01-09

Official Correspondent

Kyron Nielsen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Leavitt Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016008117 Lumea, Cedar City Cedar City, UT, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012104009. Last updated year: 2026. Please use registration number 3012104009 when referencing this establishment in official correspondence.
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