SEPPIM SAS

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0178-2014Class IICalcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. September 4, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K103376ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CNovember 18, 2011
K100547ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAMay 19, 2011
K102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLMay 19, 2011
K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSMay 6, 2011
K100525ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMSDecember 15, 2010
K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-05September 20, 2010
K832460TRIGLYCERIDE REAGENT-TRINDER-GPOSeptember 12, 1983