SEPPIM SAS
FDA Regulatory Profile
SEPPIM SAS appears in FDA public data with 1 recall, 7 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0178-2014, Class II) was initiated on September 4, 2013. Its most recent 510(k) clearance was granted on November 18, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0178-2014 | Class II | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. | September 4, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL C | November 18, 2011 |
| K100547 | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICA | May 19, 2011 |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | May 19, 2011 |
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | May 6, 2011 |
| K100525 | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS | December 15, 2010 |
| K093883 | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-05 | September 20, 2010 |
| K832460 | TRIGLYCERIDE REAGENT-TRINDER-GPO | September 12, 1983 |