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510(k) K241220

Tina-quant Lipoprotein(a) Gen.2 Molarity by Roche Diagnostics Operations — Product Code DFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2025
Date Received
May 1, 2024
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 Roche Diagnostics Operations

  • K233454 — ONLINE TDM Methotrexate (February 20, 2024)
  • K163633 — cobas HbA1c Test, cobas b 101 system (July 28, 2017)
  • K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (October 11, 2013)
  • K131029 — ACCU-CHEK AVIVA PLUS TEST STRIP (August 9, 2013)
  • K121610 — COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY (August 8, 2013)
  • K113072 — TINA-QUANT ALBUMIN GEN.2 (May 14, 2012)

Other clearances for product code DFC

  • 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)
  • K021660 — K-ASSAY LP(A) ASSAY (July 25, 2002)
  • K013359 — LP(A)-LATEX SEIKEN ASSAY KIT (March 8, 2002)