FDA applicant

Boehringer Mannheim Italia Spa

Simi Valley, CA3 decisions1994–19960 recalls

FDA records 3 decisions for Boehringer Mannheim Italia Spa (Simi Valley, CA) from 1994 to 1996: 3 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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, clinical chemistry panel, where it files most

How often FDA has decided Boehringer Mannheim Italia Spa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boehringer Mannheim Italia Spa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Boehringer Mannheim Italia Spa by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Boehringer”

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

Boehringer Mannheim Corp. 341 Boehringer Laboratories 44 Boehringer Ingelheim Pharmaceuticals, Inc. 2 Boehringer/Miter, Inc. 1

Boehringer Mannheim Italia Spa

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Boehringer”