Contract manufacturerOSANG LLC (S Pasadena, CA)CaliforniaClinical chemistryClass IIClass I
OSANG LLC
Contract manufacturer · S Pasadena, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3020885868 (openFDA record; or search FDA's registration database)
- FEI number
- 3020885868
- Registered for
- FDA registration year 2027
- Establishment types
- Complaint file establishment; Specification developer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- OSANG HEALTHCARE CO., LTD. (FDA owner/operator no. 9056376)
- Registered address
- 625 Fair Oaks Ave Ste 360, S Pasadena, CA 91030
- Contract listings
- 5 device listings, 7 product codes, first listed Jul 14, 2009
- 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 |
|---|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Class II | Clinical chemistry | Contract manufacturing | Jul 14, 2009 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | Class I | Clinical chemistry | Contract manufacturing | Jun 26, 2013 |
| JGY | Colorimetric Method, Triglycerides | Class I | Clinical chemistry | Contract manufacturing | Jun 26, 2013 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Jul 14, 2009 |
| LBR | Ldl & Vldl Precipitation, Hdl | Class I | Clinical chemistry | Contract manufacturing | Jun 26, 2013 |
| LFR | Glucose Dehydrogenase, Glucose | Class II | Clinical chemistry | Contract manufacturing | Dec 17, 2013 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | Clinical chemistry | Contract manufacturing | Jul 14, 2009 |