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510(k) K082488

DIAZYME LP(A) ASSAY by General Atomics — Product Code DFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2009
Date Received
August 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5600
Review Panel
IM
Submission Type

Other clearances by General Atomics

  • K072977 — DIAZYME APOLIPOPROTEIN A-1 ASSAY (July 16, 2008)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (January 22, 2008)
  • K050178 — HBA1C ENZYMATIC ASSAY (June 28, 2005)
  • K042448 — DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT (October 29, 2004)
  • K033360 — DIAZYME LITHIUM ENZYMATIC ASSAY KIT (December 23, 2003)

Other clearances for product code DFC

  • K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity (January 24, 2025)
  • K211058 — Lp(a) Ultra (December 22, 2022)
  • K180074 — Diazyme Lipoprotein (a) Assay (March 22, 2018)
  • K123046 — ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (December 20, 2012)
  • K122722 — COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A (November 29, 2012)
  • K063838 — LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (September 27, 2007)
  • K050487 — QUANTIA LA(A) (April 26, 2005)
  • K023853 — K-ASSAY LP(A) CONTROLS (December 13, 2002)
  • K021660 — K-ASSAY LP(A) ASSAY (July 25, 2002)
  • K013359 — LP(A)-LATEX SEIKEN ASSAY KIT (March 8, 2002)