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FDA 510(k)

QNext and DG-PT

K-Number: K183390 · 2019-08-21

ApplicantDiagnostic Grifols, S.A.
Decision Date2019-08-21
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QNext and DG-PT is a medical device manufactured by Diagnostic Grifols, S.A.. It received FDA 510(k) clearance on 2019-08-21 under approval 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. It is manufactured by Diagnostic Grifols, S.A.. The 510(k) number is K183390.

When was QNext and DG-PT approved by the FDA?

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

What company makes QNext and DG-PT?

QNext and DG-PT is manufactured by Diagnostic Grifols, S.A..

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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