FDA applicant
Seppim S.A.S.
FDA records 7 decisions for Seppim S.A.S. (Bothell, WA) from 1983 to 2011: 7 510(k) clearances. Most are in product codes CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot) and CGA (Glucose Oxidase, Glucose). Its devices cite 20 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Seppim, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Seppim S.A.S.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2011
2026 so far, outlined.
Recalls per year
4in 2015
Class I Class II/III not classified
Planning a device like Seppim S.A.S.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report