Medical Device Manufacturer · US , Bothell , WA

Seppim S.A.S.

6 submissions · 6 cleared · Since 2010
6
Total
6
Cleared
0
Denied

Seppim S.A.S. — FDA 510(k) Submissions

Seppim S.A.S. has submitted 6 FDA 510(k) premarket notifications since 2010, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Nadh Oxidation/nad Reduction, Ast/sgot, Phosphomolybdate (colorimetric), Inorganic Phosphorus, Glucose Oxidase, Glucose, Assay, Glycosylated Hemoglobin, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides . Use the specialty filter in the sidebar to narrow results.

6 devices
1–6 of 6
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
K103376 · JFY Enzymatic Method, Creatinine · Chemistry
Nov 2011 366d
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
K100547 · LCP Assay, Glycosylated... · Chemistry
May 2011 448d
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
K102993 · CDT Lipase... · Chemistry
May 2011 223d
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
K100263 · CEO Phosphomolybdate... · Chemistry
May 2011 463d
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
K100525 · CGA Glucose Oxidase, Glucose · Chemistry
Dec 2010 294d
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-
K093883 · CIT Nadh Oxidation/nad... · Chemistry
Sep 2010 276d
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