Contract manufacturerACON LABORATORIES, INC. (San Diego, CA)CaliforniaClinical chemistryClass IIClass I
ACON LABORATORIES, INC.
Contract manufacturer ยท San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2531491 (openFDA record; or search FDA's registration database)
- FEI number
- 3003516723
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- ACON Laboratories, Inc. (FDA owner/operator no. 9063887)
- Registered address
- 9440 Carroll Park Dr, San Diego, CA 92121
- Contract listings
- 1 device listings, 3 product codes, first listed Nov 5, 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 |
|---|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Class II | Clinical chemistry | Contract manufacturing | Nov 5, 2020 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Nov 5, 2020 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | Clinical chemistry | Contract manufacturing | Nov 5, 2020 |