Contract manufacturerLABCON, NORTH AMERICA (Petaluma, CA)CaliforniaHematologyPathologyClass I
LABCON, NORTH AMERICA
Contract manufacturer ยท Petaluma, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2916657 (openFDA record; or search FDA's registration database)
- FEI number
- 2916657
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- HELENA LABORATORIES, CORP. (FDA owner/operator no. 1618982)
- Registered address
- 3700 LAKEVILLE HWY., STE. 200, Petaluma, CA 94954
- Contract listings
- 5 device listings, 5 product codes, first listed Dec 19, 2012
- 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 |
|---|---|---|---|---|---|
| GJG | Pipette, Quantitative, Hematology | Class I | Hematology | Contract manufacturing | Jan 22, 2013 |
| KDT | Container, Specimen Mailer And Storage, Sterile | Class I | Pathology | Contract manufacturing | Dec 19, 2012 |
| KJG | Tube, Tissue Culture | Class I | Pathology | Contract manufacturing | Dec 19, 2012 |
| NNI | Container, Specimen, Non-Sterile | Class I | Pathology | Contract manufacturing | Dec 19, 2012 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Class I | Pathology | Contract manufacturing | Dec 19, 2012 |