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510(k) K102993

ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL by Seppim S.A.S. — Product Code CDT

K102993 is an FDA 510(k) premarket notification submitted by Seppim S.A.S. for the device "ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL". The FDA issued a decision of Substantially Equivalent on May 19, 2011. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Seppim S.A.S. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2011
Date Received
October 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Seppim S.A.S.

  • K103376 — ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYST (November 18, 2011)
  • K100547 — ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR (May 19, 2011)
  • K100263 — ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (May 6, 2011)
  • K100525 — ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELIT (December 15, 2010)
  • K093883 — AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250 (September 20, 2010)
  • K832460 — TRIGLYCERIDE REAGENT-TRINDER-GPO (September 12, 1983)

Other clearances for product code CDT

  • K150819 — Triglycerides (August 6, 2015)
  • K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (November 22, 2013)
  • K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES (May 31, 2013)
  • K113830 — VANTERA CLINICAL ANALYZER (August 30, 2012)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K043546 — DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (January 18, 2005)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K010871 — TGL FLEX REAGENT CARTRIDGE (July 9, 2001)
  • K993466 — WAKO L-TYPE TRIGLYCERIDE TEST (November 9, 1999)

FDA data resources