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510(k) K021660

K-ASSAY LP(A) ASSAY by Kamiya Biomedical Co. — Product Code DFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2002
Date Received
May 20, 2002
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 Kamiya Biomedical Co.

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  • K093137 — K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (September 28, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K050944 — K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (December 23, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C (June 27, 2003)
  • K023828 — K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULT (February 4, 2003)
  • K023853 — K-ASSAY LP(A) CONTROLS (December 13, 2002)
  • K022486 — K-ASSAY HS-CRP CONTROLS (August 14, 2002)

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)
  • 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)
  • K013359 — LP(A)-LATEX SEIKEN ASSAY KIT (March 8, 2002)