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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Life Technologies Corporation. It received FDA 510(k) clearance on 2017-06-22 under 510(k) 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. The listed applicant is Life Technologies Corporation. The 510(k) number is K170299.

When did Ion PGM Dx System receive FDA 510(k) clearance?

Ion PGM Dx System received FDA 510(k) clearance on 2017-06-22, under 510(k) number K170299.

Who is the listed applicant for Ion PGM Dx System?

The FDA 510(k) record lists Life Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ion PGM Dx System?

The FDA product code for Ion PGM Dx System is PFF.

Other records listing Life Technologies Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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