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510(k) K180835

SEKURE Acetaminophen L3K Assay by Sekisui Diagnostics P.E.I., Inc. — Product Code LDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2019
Date Received
March 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Acetaminophen
Device Class
Class II
Regulation Number
862.3030
Review Panel
TX
Submission Type

Other clearances by Sekisui Diagnostics P.E.I., Inc.

  • K202644 — Acetaminophen (February 18, 2022)
  • K182702 — SEKURE Creatine Kinase Assay (April 17, 2019)
  • K173206 — SEKURE HbA1c Assay (July 12, 2018)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K111915 — MAGNESIUM ASSAY (December 2, 2011)

Other clearances for product code LDP

  • K202644 — Acetaminophen (February 18, 2022)
  • K110726 — ROCHE ACETAMINOPHEN ASSAY (December 23, 2011)
  • K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 (August 2, 2010)
  • K081938 — ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 (May 1, 2009)
  • K061655 — DIMENSION VISTA FLEX REAGENT CARTRIDGES (July 10, 2006)
  • K043242 — TRIAGE TOX DRUG SCREEN (February 28, 2005)
  • K042330 — ACETAMINOPHEN-SL ASSAY (January 7, 2005)
  • K020792 — ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (July 11, 2002)
  • K013757 — ROCHE ACETAMINOPHEN (January 8, 2002)
  • K011465 — SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO (June 8, 2001)