510(k) K170299
K170299 is an FDA 510(k) premarket notification submitted by Life Technologies Corporation for the device "Ion PGM Dx System". The FDA issued a decision of Substantially Equivalent on June 22, 2017. The device falls under product code PFF (High Throughput Dna Sequence Analyzer), a Class II device regulated under 21 CFR 862.2265. Life Technologies Corporation has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2017
- Date Received
- January 31, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Throughput Dna Sequence Analyzer
- Device Class
- Class II
- Regulation Number
- 862.2265
- Review Panel
- TX
- Submission Type
A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.