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510(k) K062316

DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE by Dade Behring, Inc. — Product Code JIF

K062316 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on September 6, 2006. The device falls under product code JIF (Enzymatic Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2006
Date Received
August 9, 2006
Clearance Type
Special
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

Other clearances by Dade Behring, Inc.

  • K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07 (December 20, 2010)
  • K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (July 28, 2008)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code JIF

  • K183517 — Ammonia II (February 8, 2019)
  • K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (C (March 7, 2013)
  • K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (February 15, 2013)
  • 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