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510(k) K170299

Ion PGM Dx System by Life Technologies Corporation — Product Code PFF

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.

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  • K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (March 8, 2013)
  • K103302 — STEMPRO MSC SFM (February 18, 2011)
  • K100616 — KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (May 20, 2010)

Other clearances for product code PFF

  • DEN130011 — ILLUMINA MISEQDX PLATFORM (November 19, 2013)