Ion PGM Dx System
FDA 510(k) K170299 · Life Technologies Corporation
510(k) numberK170299
Submission
- Device name
- Ion PGM Dx System
- Applicant
- Life Technologies Corporation
Carlsbad, CA, US - Received
- January 31, 2017
- Decision date
- June 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PFF – High Throughput Dna Sequence Analyzer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2265
- Specialty
- Immunology
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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Questions and answers
When was Ion PGM Dx System cleared by the FDA?
Ion PGM Dx System (K170299) received a 510(k) decision of Substantially Equivalent on June 22, 2017, 142 days after the submission was received.
What is the product code of K170299?
The FDA product code is PFF – High Throughput Dna Sequence Analyzer, a Class II (moderate risk) device regulated under 21 CFR 862.2265.