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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