510(k) K170299
- Device
- Ion PGM Dx System
- Applicant
- LIFE TECHNOLOGIES CORPORATION
- 510(k) number
- K170299
- Product code
- PFF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-22
- Date received
- 2017-01-31
- Regulation
- 862.2265
- Classification name
- High Throughput Dna Sequence Analyzer
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EMILY FINNEGAN
- Address
- 5781 Van Allen Way Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3006296346
- 3014150341
- 3003673482
- 3003335080
- 3003218906
- 3009207631
- 3007287152
- 3015529000
- 3009875001
- 3011104381
- 3007102730
Source Documents#
Other 510(k) Records For Product Code PFF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN130011 | ILLUMINA MISEQDX PLATFORM | Illumina, Inc. | 2013-11-19 |
Legacy Summary#
summary
FDA Review#
Decision Summary