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510(k) K183517

Ammonia II by Roche Diagnostics Operations (Rdo) — Product Code JIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2019
Date Received
December 18, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Ammonia
Device Class
Class I
Regulation Number
862.1065
Review Panel
CH
Submission Type

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Other clearances for product code JIF

  • K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (C (March 7, 2013)
  • K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (February 15, 2013)
  • K062316 — DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (September 6, 2006)
  • K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (November 25, 2005)
  • K033921 — AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 (March 10, 2004)
  • K030873 — RANDOX AMMONIA (May 12, 2003)
  • K023841 — AMMONIA ASSAY FOR THE ADVIA 1650 (December 24, 2002)
  • K021151 — AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (July 13, 2002)
  • K003196 — SYNCHRON SYSTEMS AMMONIA REAGENT (December 22, 2000)
  • K001285 — AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 (June 2, 2000)