The following data is part of a premarket notification filed by Life Technologies Corporation with the FDA for Ion Pgm Dx System.
| Device ID | K170299 |
| 510k Number | K170299 |
| Device Name: | Ion PGM Dx System |
| Classification | High Throughput Dna Sequence Analyzer |
| Applicant | LIFE TECHNOLOGIES CORPORATION 5781 VAN ALLEN WAY Carlsbad, CA 92008 |
| Contact | Emily Finnegan |
| Correspondent | Emily Finnegan LIFE TECHNOLOGIES CORPORATION 5781 VAN ALLEN WAY Carlsbad, CA 92008 |
| Product Code | PFF |
| CFR Regulation Number | 862.2265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-31 |
| Decision Date | 2017-06-22 |
| Summary: | summary |