ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL— 510(k) K103376
Substantially EquivalentSeppim S.A.S.
FDA 510(k) clearance K103376 for ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL, Substantially Equivalent on 2011-11-18. Applicant: Seppim S.A.S.. Device class: 2.
Clearance details
- Applicant
- Seppim S.A.S.
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code JFY
view allMore clearances from Seppim S.A.S.
view all- K100547 — ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
- K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
- K100263 — ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
- K100525 — ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
- K093883 — 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-
Data sourced from openFDA. This site is unofficial and independent of the FDA.