Contract manufacturerGL DIABETES CORPORATION (San Diego, CA)CaliforniaClinical chemistryClass IClass II
GL DIABETES CORPORATION
Contract manufacturer ยท San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009129531 (openFDA record; or search FDA's registration database)
- FEI number
- 3009129531
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- GL DIABETES CORPORATION (FDA owner/operator no. 10035802)
- Registered address
- 9676 Oviedo St, San Diego, CA 92129
- Contract listings
- 7 device listings, 4 product codes, first listed Dec 30, 2014
- 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 |
|---|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Dec 30, 2014 |
| JQP | Calculator/Data Processing Module, For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Aug 4, 2015 |
| LFR | Glucose Dehydrogenase, Glucose | Class II | Clinical chemistry | Contract manufacturing | Dec 30, 2014 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | Clinical chemistry | Contract manufacturing | Dec 30, 2014 |