FDA applicant

Roche Diagnostics Hematology, Inc.

Westborough, MA1 decision2018–20181 recall

FDA records 1 decision for Roche Diagnostics Hematology, Inc. (Westborough, MA) in 2018: 1 510(k) clearance. All are in product code GKZ (Counter, Differential Cell). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Roche Diagnostics Hematology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Roche Diagnostics Hematology, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Roche Diagnostics Hematology, Inc.’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 “Roche”

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

Roche Diagnostics Corp. 480 Roche Diagnostic Systems, Inc. 296 Roche Molecular Systems, Inc. 70 Roche Medical Electronics, Inc. 16 Roche Diagnostics Operations (Rdo) 14 Roche Diabetes Care, Inc. 13 Roche Analytical Instruments, Inc. 11 Roche Diagnostics Operations 9 Roche 3 Roche Diagnostics/Boehringer Mannheim GmbH 3 Roche Professional Diagnostics 2 Roche Molecular System, Inc. 1

Roche Diagnostics Hematology, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Roche”