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510(k) K034000

VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR by Clinical Data, Inc. — Product Code CDT

K034000 is an FDA 510(k) premarket notification submitted by Clinical Data, Inc. for the device "VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR". The FDA issued a decision of Substantially Equivalent on March 10, 2004. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Clinical Data, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2004
Date Received
December 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Clinical Data, Inc.

  • K071706 — ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55 (December 20, 2007)
  • K052591 — NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT (February 9, 2006)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K040631 — VITALAB DIRECT BILIRUBIN REAGENT (March 18, 2004)
  • K040534 — VITALAB AMYLASE REAGENT (March 11, 2004)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K031042 — ATAC HEMOGLOBIN A1C REAGENT KIT (November 3, 2003)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)
  • K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (June 17, 2003)

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)
  • 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