510(k) Report

FDA applicant

Skd, Inc. A Beckman Coulter Co.

Palo Alto, CA1 decision1998–19980 recalls

FDA records 1 decision for Skd, Inc. A Beckman Coulter Co. (Palo Alto, CA) in 1998: 1 510(k) clearance. All are in product code JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Skd, Inc. A Beckman Coulter Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Skd, Inc. A Beckman Coulter Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Skd, Inc. A Beckman Coulter Co.’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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