510(k) Report

FDA applicant

Premd, Inc.

Rockville, MD1 decision2006–20060 recalls

FDA records 1 decision for Premd, Inc. (Rockville, MD) in 2006: 1 510(k) clearance. All are in product code LBS (Ldl & Vldl Precipitation, Cholesterol Via…). 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 Premd, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Premd, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Premd, 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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