FDA applicant

Diatech, Inc.

Mchenry, IL17 decisions1984–19880 recalls

FDA records 17 decisions for Diatech, Inc. (Mchenry, IL) from 1984 to 1988: 17 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and GGP (Test, Qualitative And Quantitative Factor…). 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 Diatech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diatech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Diatech, 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 “Diatech”

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

Diatech Diagnostica, Ltd. 3 Diatech Diagnostics,Inc. 1

Diatech, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Diatech”