QNext and DG-PT— 510(k) K183390

Substantially Equivalent

Diagnostic Grifols, S.A.

FDA 510(k) clearance K183390 for QNext and DG-PT, Substantially Equivalent on 2019-08-21. Applicant: Diagnostic Grifols, S.A..

Clearance details

Applicant: Diagnostic Grifols, S.A.
Product code: Code JPA
Advisory panel: Hematology
Date received: 2018-12-06
Decision date: 2019-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Partes Del Valles, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.