Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Seppim S.A.S. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
366 daysmedian FDA review time
463 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, C | Seppim S.A.S. | 2011-11-18 | 366 | 0 |
| K100547 | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYST | Seppim S.A.S. | 2011-05-19 | 448 | 0 |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL | Seppim S.A.S. | 2011-05-19 | 223 | 0 |
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND U | Seppim S.A.S. | 2011-05-06 | 463 | 0 |
| K100525 | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYS | Seppim S.A.S. | 2010-12-15 | 294 | 4 |
| K093883 | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL | Seppim S.A.S. | 2010-09-20 | 276 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda