FDA applicant
Aalto Scientific, Ltd.
FDA records 35 decisions for Aalto Scientific, Ltd. (Carlsbad, CA) from 1982 to 2017: 35 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 32 predicates, 25 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aalto Scientific, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
2in 2021
Class I Class II/III not classified
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