FDA 510(k)

QNext and DG-PT

K-Number: K183390 · 2019-08-21

Decision Date2019-08-21

Product CodeJPA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

QNext and DG-PT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Grifols, S.A.. It received FDA 510(k) clearance on 2019-08-21 under 510(k) number K183390. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QNext and DG-PT?

QNext and DG-PT is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Diagnostic Grifols, S.A.. The 510(k) number is K183390.

When did QNext and DG-PT receive FDA 510(k) clearance?

QNext and DG-PT received FDA 510(k) clearance on 2019-08-21, under 510(k) number K183390.

Who is the listed applicant for QNext and DG-PT?

The FDA 510(k) record lists Diagnostic Grifols, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QNext and DG-PT?

The FDA product code for QNext and DG-PT is JPA.

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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.