FDA 510(k)

GenetiSure Dx Postnatal Assay

K-Number: K163367 · 2017-08-11

Decision Date2017-08-11

Product CodePFX

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

GenetiSure Dx Postnatal Assay is a medical device manufactured by Agilent Technologies, Inc.. It received FDA 510(k) clearance on 2017-08-11 under approval number K163367. The device is classified under product code PFX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GenetiSure Dx Postnatal Assay?

GenetiSure Dx Postnatal Assay is a medical device that received FDA 510(k) clearance on 2017-08-11. It is manufactured by Agilent Technologies, Inc.. The 510(k) number is K163367.

When was GenetiSure Dx Postnatal Assay approved by the FDA?

GenetiSure Dx Postnatal Assay received FDA 510(k) clearance on 2017-08-11, under approval number K163367.

What company makes GenetiSure Dx Postnatal Assay?

GenetiSure Dx Postnatal Assay is manufactured by Agilent Technologies, Inc..

What is the FDA product code for GenetiSure Dx Postnatal Assay?

The FDA product code for GenetiSure Dx Postnatal Assay is PFX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.