Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014717638

FEI Number

3014717638

Entity Name

TN MICHIGAN, LLC

City/State/Country

Sault Sainte Marie, MI, US

Establishment Address

1390 Industrial Park Drive, Sault Sainte Marie, MI 49783, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TN Michigan, LLC (Owner Number: 10075464)

Owner / Operator Contact Address

1390 Industrial Park Drive, Sault Sainte Marie, MI 49783, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IMMULITE 2000 Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSX	Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use	Hematology	Class 2	864.9160	2020-06-16
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2021-08-30

Official Correspondent

John Geukes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TN Michigan, LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
3017237798	HEMO BIOSCIENCE	Durham, NC, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
1034569	IMMUCOR, INC.	Norcross, GA, US
2029372	Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, US
3007500635	Immunodiagnostic Systems SA	Liege, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014717638. Last updated year: 2026. Please use registration number 3014717638 when referencing this establishment in official correspondence.