FDA applicant

Diagnostica, Inc.

Mchenry, IL12 decisions1978–20010 recalls

FDA records 12 decisions for Diagnostica, Inc. (Mchenry, IL) from 1978 to 2001: 12 510(k) clearances. Most are in product codes DEW (Igg, Antigen, Antiserum, Control) and GRP (Antisera, All Types, H. Influenza). 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, immunology panel, where it files most

How often FDA has decided Diagnostica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnostica, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Diagnostica”

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

Diagnostica Stago, Inc. 25

Diagnostica, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Diagnostica”