FDA applicant

Diagnostic Grifols, S.A.

Partes Del Valles, ES1 decision2019–20190 recalls

FDA records 1 decision for Diagnostic Grifols, S.A. (Partes Del Valles, ES) in 2019: 1 510(k) clearance. All are in product code JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Diagnostic Grifols, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Diagnostic Grifols, S.A. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Diagnostic Grifols, S.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Diagnostic”

FDA records each applicant name separately; these may or may not be the same firm.

Diagnostic Products Corp. 324 Diagnostic Systems Laboratories, Inc. 94 Diagnostic Chemicals, Ltd. (Usa) 77 Diagnostic Reagents, Inc. 66 Diagnostic Chemicals, Ltd. 66 Diagnostic Hybrids, Inc. 37 Diagnostic Technology, Inc. 28 Diagnostic Solutions, Inc. 26 Diagnostic Ultrasound Corp. 16 Diagnostic Systems 14 Diagnostic Reagent Tech. 10 Diagnostic Specialties 8

Diagnostic Grifols, S.A.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Diagnostic”