FDA applicant

Care Diagnostic, Inc.

Klamath Falls, OR1 decision2006–20060 recalls

FDA records 1 decision for Care Diagnostic, Inc. (Klamath Falls, OR) in 2006: 1 510(k) clearance. 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 Care Diagnostic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Care Diagnostic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Care Diagnostic, Inc.

Which product codes does it file in?

What has FDA decided for it lately?