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510(k) K811850

ESKAFLOW TEST FOR TRIGLYCERIDES by Smithkline Diagnostics, Inc. — Product Code CDT

K811850 is an FDA 510(k) premarket notification submitted by Smithkline Diagnostics, Inc. for the device "ESKAFLOW TEST FOR TRIGLYCERIDES". The FDA issued a decision of Substantially Equivalent on July 23, 1981. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Smithkline Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1981
Date Received
July 1, 1981
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 Smithkline Diagnostics, Inc.

  • K961062 — FLEXSURE OBT (November 6, 1996)
  • K960183 — FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS F (June 7, 1996)
  • K934863 — FLEXSURE HP (May 18, 1994)
  • K880499 — HEMOCCULT SENSITIVE TEST (May 23, 1988)
  • K875131 — (SKD) CHOLESTEROL TEST KIT (March 1, 1988)
  • K862849 — HEMOCCULT WIPE TEST (December 9, 1986)
  • K854723 — SKD ELECTROCHEMICAL SYSTEM (ECS) (March 5, 1986)
  • K852841 — RAPID DIRECT STREP A LATEX AGGLUTINATION TEST (July 24, 1985)
  • K821884 — GASTROCCULT TM (October 8, 1982)
  • K821674 — SPINCHEM ACID PHOSPHATASE REAGENT (June 22, 1982)

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)
  • K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL (May 19, 2011)
  • 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)

FDA data resources