FDA applicant

Aerscher Diagnostics

Chestertown, MD3 decisions1997–20030 recalls

FDA records 3 decisions for Aerscher Diagnostics (Chestertown, MD) from 1997 to 2003: 3 510(k) clearances. All are in product code KHE (Reagent, Occult Blood). 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 Aerscher Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aerscher Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Aerscher”

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

Aerscher, Inc. 1

Aerscher Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Aerscher”