Data / Medical devices / United States / Illumina, Inc. Hayward
Illumina, Inc. Hayward: FDA-registered device maker in Hayward, CA, United States, 1 510(k) clearance
Illumina, Inc. Hayward is registered with the FDA (registration 3006296346) in Hayward, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2013. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006296346
- FEI number
- 3005095756
- Address
- 25841 Industrial Blvd, Hayward, CA, United States, 94545
- Owner or operator
- Illumina, Inc. (10030352)
- Roles
- Manufacturer
- First device listed
- January 10, 2014
- Registered through
- 2026
- Brand names listed
- Illumina DRAGEN Server for NextSeq 550Dx, MiSeqDx, MiSeqDx China, NextSeq 550Dx Instrument, NovaSeq 6000Dx Instrument
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| High Throughput Dna Sequence Analyzer | PFF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2013 | DEN130011 | ILLUMINA MISEQDX PLATFORM | PFF | Unknown | Illumina, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 19, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.