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510(k) K842443

AXIOM STABLE II TRIGLYCERIDES TEST by Axiom, Inc. — Product Code CDT

K842443 is an FDA 510(k) premarket notification submitted by Axiom, Inc. for the device "AXIOM STABLE II TRIGLYCERIDES TEST". The FDA issued a decision of Substantially Equivalent on September 13, 1984. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Axiom, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1984
Date Received
June 21, 1984
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 Axiom, Inc.

  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K842442 — AXIOM STABLE II URIC ACID TEST (August 16, 1984)
  • K842441 — AXIOM STABLE II CHOLESTEROL TEST (July 25, 1984)

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