Contract manufacturerTN MICHIGAN, LLC (Sault Sainte Marie, MI)MichiganClinical chemistryHematologyClass IClass II
TN MICHIGAN, LLC
Contract manufacturer ยท Sault Sainte Marie, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3014717638 (openFDA record; or search FDA's registration database)
- FEI number
- 3014717638
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- TN Michigan, LLC (FDA owner/operator no. 10075464)
- Registered address
- 1390 Industrial Park Drive, Sault Sainte Marie, MI 49783
- Contract listings
- 2 device listings, 2 product codes, first listed Jun 16, 2020
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Aug 30, 2021 |
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | Class II | Hematology | Contract manufacturing | Jun 16, 2020 |