Ion PGM Dx System
K-Number: K170299 · 2017-06-22
ApplicantLife Technologies Corporation
Decision Date2017-06-22
Product CodePFF
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Ion PGM Dx System is a medical device manufactured by Life Technologies Corporation. It received FDA 510(k) clearance on 2017-06-22 under approval number K170299. The device is classified under product code PFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ion PGM Dx System?
Ion PGM Dx System is a medical device that received FDA 510(k) clearance on 2017-06-22. It is manufactured by Life Technologies Corporation. The 510(k) number is K170299.
When was Ion PGM Dx System approved by the FDA?
Ion PGM Dx System received FDA 510(k) clearance on 2017-06-22, under approval number K170299.
What company makes Ion PGM Dx System?
Ion PGM Dx System is manufactured by Life Technologies Corporation.
What is the FDA product code for Ion PGM Dx System?
The FDA product code for Ion PGM Dx System is PFF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.