FDA applicant

Btc Diagnostics, Inc.

Mchenry, IL5 decisions1983–19840 recalls

FDA records 5 decisions for Btc Diagnostics, Inc. (Mchenry, IL) from 1983 to 1984: 5 510(k) clearances. Most are in product codes JHJ (Agglutination Method, Human Chorionic…) and CEP (Radioimmunoassay, Luteinizing Hormone). 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 Btc Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Btc Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Btc Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?