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FDA 510(k)

GenetiSure Dx Postnatal Assay

K-Number: K163367 · 2017-08-11

ApplicantAgilent Technologies, Inc.
Decision Date2017-08-11
Product CodePFX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GenetiSure Dx Postnatal Assay is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies, Inc.. It received FDA 510(k) clearance on 2017-08-11 under 510(k) 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. The listed applicant is Agilent Technologies, Inc.. The 510(k) number is K163367.

When did GenetiSure Dx Postnatal Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for GenetiSure Dx Postnatal Assay?

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

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

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

Other records listing Agilent Technologies, Inc. as applicant

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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.

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