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510(k) K000494

SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT by Beckman Coulter, Inc. — Product Code LDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2000
Date Received
February 15, 2000
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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Other clearances for product code LDP

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  • 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)