Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011260354

FEI Number

3011260354

Entity Name

MEDTOX Diagnostics, Inc.

City/State/Country

Pleasanton, CA, US

Establishment Address

6624 Owens Drive, Pleasanton, CA 94588, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDTOX DIAGNOSTICS, INC. (Owner Number: 1050155)

Owner / Operator Contact Address

1238 ANTHONY RD., --, Burlington, NC 27215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153683

PMA Number

N/A

All Registered Proprietary Names

Labcorp Comfort Draw

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2026-05-18
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2021-10-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDTOX DIAGNOSTICS, 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
1050155	MEDTOX DIAGNOSTICS, INC.	BURLINGTON, NC, US
3004175381	MEDTOX DIAGNOSTICS, INC.	BURLINGTON, NC, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011260354. Last updated year: 2026. Please use registration number 3011260354 when referencing this establishment in official correspondence.