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510(k) K123677

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) by Siemens Healthcare Diagnostics — Product Code JIF

K123677 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)". The FDA issued a decision of Substantially Equivalent on March 7, 2013. The device falls under product code JIF (Enzymatic Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2013
Date Received
November 30, 2012
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

  • K183517 — Ammonia II (February 8, 2019)
  • 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)

FDA data resources