Seppim S.A.S.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Seppim S.A.S.” (first 2010, latest 2011), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 330 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Hematology (1)
Most recent Seppim S.A.S. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL | JFY | 2011-11-18 | 366 |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | CDT | 2011-05-19 | 223 |
| K100547 | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL | LCP | 2011-05-19 | 448 |
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | CEO | 2011-05-06 | 463 |
| K100525 | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 | CGA | 2010-12-15 | 294 |
| K093883 | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- | CIT | 2010-09-20 | 276 |
Recalls
openFDA lists no recalls under a recalling firm named Seppim S.A.S..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Seppim, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Seppim S.A.S.?
FDA lists 6 510(k) clearances under the applicant name “Seppim S.A.S.” (first 2010, latest 2011), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Seppim S.A.S.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seppim S.A.S. is 330 days.
Which FDA product codes appear under Seppim S.A.S.?
The most frequent FDA product codes under this applicant name are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1); CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus, 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 6 Seppim S.A.S. clearances with predicates and recalls
- Run predicate analysis for product code CDT, Seppim S.A.S.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.