Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006793669

FEI Number

3006793669

Entity Name

ML LifeSciences

City/State/Country

Irvine, CA, US

Establishment Address

17 Hammond, Suite 408, Irvine, CA 92618, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ML LifeSciences (Owner Number: 10023336)

Owner / Operator Contact Address

17 Hammond, Suite 408, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bio Med QC Therapak Corporation Path-Tec QI Medical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2013-12-02

Official Correspondent

Laura Lovely

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ML LifeSciences

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006793669. Last updated year: 2026. Please use registration number 3006793669 when referencing this establishment in official correspondence.