K170299 is an FDA 510(k) clearance for the Ion PGM Dx System. This device is classified as a High Throughput Dna Sequence Analyzer (Class II - Special Controls, product code PFF).
Submitted by Life Technologies Corporation (Carlsbad, US). The FDA issued a Cleared decision on June 22, 2017, 142 days after receiving the submission on January 31, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2265. 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..
| 510(k) Number | K170299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2017 |
| Decision Date | June 22, 2017 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PFF - High Throughput Dna Sequence Analyzer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.2265 |
| Definition | 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. |