Contract manufacturerBeckman Coulter, Inc. (Hebron, KY)KentuckyHematologyPathologyClinical chemistryClass IClass II
Beckman Coulter, Inc.
Contract manufacturer ยท Hebron, KY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3008629785 (openFDA record; or search FDA's registration database)
- FEI number
- 3008629785
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- BECKMAN COULTER, INC. (FDA owner/operator no. 2050012)
- Registered address
- 2295 Progress Dr., Suite C, Hebron, KY 41048
- Contract listings
- 5 device listings, 5 product codes, first listed Dec 14, 1977
- 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 |
|---|---|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | Class I | Hematology | Contract manufacturing | Dec 14, 1977 |
| GIF | Diluent, Blood Cell | Class I | Hematology | Contract manufacturing | Dec 14, 1977 |
| JCB | Detergent | Class I | Pathology | Contract manufacturing | Dec 14, 1977 |
| JGS | Electrode, Ion Specific, Sodium | Class II | Clinical chemistry | Contract manufacturing | Aug 13, 2009 |
| PPM | General Purpose Reagent | Class I | Pathology | Contract manufacturing | Jul 24, 2006 |