Home / 510(k) Clearances / K180074

510(k) K180074

Diazyme Lipoprotein (a) Assay by Diazyme Laboratories, Inc. — Product Code DFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2018
Date Received
January 10, 2018
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 Diazyme Laboratories, Inc.

  • K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Li (December 19, 2025)
  • K243462 — Diazyme Colorimetric Lithium Assay (August 1, 2025)
  • K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (September 8, 2022)
  • K220001 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (August 4, 2022)
  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity (August 6, 2021)
  • K180209 — Diazyme 1,5-AG Assay (October 4, 2018)
  • K181438 — Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chai (June 26, 2018)
  • K172992 — Diazyme EZ Vitamin D Assay (January 11, 2018)
  • K163418 — Diazyme DZ-Lite Total beta-hCG Test System (August 18, 2017)

Other clearances for product code DFC

  • K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity (January 24, 2025)
  • K211058 — Lp(a) Ultra (December 22, 2022)
  • 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)
  • K082488 — DIAZYME LP(A) ASSAY (January 13, 2009)
  • 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)