510(k) Report

FDA applicant

Care Products, Inc.

Waterbury, CT1 decision2003–20030 recalls

FDA records 1 decision for Care Products, Inc. (Waterbury, CT) in 2003: 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 Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Care Products, 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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