Ion PGM Dx System— 510(k) K170299
Substantially EquivalentLife Technologies Corporation
FDA 510(k) clearance K170299 for Ion PGM Dx System, Substantially Equivalent on 2017-06-22. Applicant: Life Technologies Corporation. Device class: 2.
Clearance details
- Applicant
- Life Technologies Corporation
- Product code
- Code PFF
- Device class
- Class 2
- Regulation
- 21 CFR 862.2265
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code PFF
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view all- K241806 — Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel
- K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
- K191030 — Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer
- K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
- K103302 — STEMPRO MSC SFM
Recalls naming K170299
K-number listed on FDA's recall record- Z-0185-2020 — Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
- Z-0186-2020 — Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
- Z-0187-2020 — 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
- Z-0188-2020 — 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 (240)A36601
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170299.
Data sourced from openFDA. This site is unofficial and independent of the FDA.