510(k) K170299 ยท PFF High Throughput Dna Sequence Analyzer
Ion PGM Dx System
| Applicant | Life Technologies Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 22, 2017 |
| Received | Jan 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2019 | Life Technologies Holdings Pte Ltd Torrent Suite Dx Software Version (IUO) 5.2
Catalog Number: A29225
OEM Customer Software: Sentosa SQ Suite Software v5.6.9 Terminated |
PFF | None listed |
| Sep 26, 2019 | Life Technologies Holdings Pte Ltd Torrent Suite Dx Software Version (IUO) 5.4
Catalog Number: A31774
OEM Customer Software: Sentosa SQ Suite Software v5.6.15 Terminated |
PFF | None listed |
| Sep 26, 2019 | Life Technologies Holdings Pte Ltd Torrent Suite Dx Software Version 5.6.4
Catalog Number:A33178
OEM Customer software: Sentosa SQ Suite Software v5.6.20
UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178 Terminated |
PFF | None listed |
| Sep 26, 2019 | Life Technologies Holdings Pte Ltd Torrent Suite Dx Software Version 5.8
Catalog Number:A36601 and A36602
OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software
UDI:(01)10190302014090 (11)000000(10)5.8 (2 Terminated |
PFF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.