FDA applicant

Selfcare, Inc.

Waltham, MA15 decisions1996–20000 recalls

FDA records 15 decisions for Selfcare, Inc. (Waltham, MA) from 1996 to 2000: 15 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and CEP (Radioimmunoassay, Luteinizing Hormone). Its devices cite 12 predicates, 3 of them its own earlier devices. 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 Selfcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Selfcare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Selfcare, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?