FDA 510(k) Applications Submitted by SEPPIM S.A.S.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K100525 |
02/24/2010 |
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 |
SEPPIM S.A.S. |
K100263 |
01/28/2010 |
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS |
SEPPIM S.A.S. |
K100547 |
02/25/2010 |
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL |
SEPPIM S.A.S. |
K102993 |
10/08/2010 |
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL |
SEPPIM S.A.S. |
K103376 |
11/17/2010 |
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL |
SEPPIM S.A.S. |
K093883 |
12/18/2009 |
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- |
SEPPIM S.A.S. |
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