FDA applicant

Bhp Diagnostix, Inc.

Mchenry, IL25 decisions1978–19900 recalls

FDA records 25 decisions for Bhp Diagnostix, Inc. (Mchenry, IL) from 1978 to 1990: 25 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and JPK (Mixture, Hematology Quality Control). 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 Bhp Diagnostix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bhp Diagnostix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bhp Diagnostix, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bhp Diagnostix, Inc.

Which product codes does it file in?

What has FDA decided for it lately?