FDA applicant
Actimed Laboratories, Inc.
FDA records 3 decisions for Actimed Laboratories, Inc. (Burlington, NJ) from 1996 to 1998: 3 510(k) clearances. Most are in product codes CHH (Enzymatic Esterase--Oxidase, Cholesterol) and JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 4 predicates, 1 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
How often FDA has decided Actimed Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Actimed Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Actimed Laboratories, 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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