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510(k) K042330

ACETAMINOPHEN-SL ASSAY by Diagnostic Chemicals , Ltd. — Product Code LDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2005
Date Received
August 27, 2004
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

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  • K060139 — CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 (April 28, 2006)
  • K060140 — CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 (April 24, 2006)
  • K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (November 10, 2005)
  • K051191 — DCL MICROALBUMIN ASSAY, MODEL 252-20 (July 5, 2005)
  • K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299- (December 27, 2004)
  • K042329 — SALICYLATE-SL ASSAY (December 27, 2004)
  • K041926 — HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 (November 23, 2004)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)

Other clearances for product code LDP

  • K202644 — Acetaminophen (February 18, 2022)
  • K180835 — SEKURE Acetaminophen L3K Assay (February 8, 2019)
  • 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)
  • 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)