510(k) DEN130011
- Device
- ILLUMINA MISEQDX PLATFORM
- Applicant
- Illumina, Inc.
- 510(k) number
- DEN130011
- Product code
- PFF
- Decision
- Unknown (DENG)
- Decision date
- 2013-11-19
- Date received
- 2013-09-23
- Regulation
- 862.2265
- Classification name
- High Throughput Dna Sequence Analyzer
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- LEANNE M KIVIHARJU
- Address
- 5200 Illumina Way San Diego CA US 92122 92122
FDA Registration Numbers#
- 3006296346
- 3014150341
- 3003673482
- 3003335080
- 3003218906
- 3009207631
- 3007287152
- 3015529000
- 3009875001
- 3011104381
- 3007102730
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PFF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170299 | Ion PGM Dx System | Life Technologies Corporation | 2017-06-22 |