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510(k) K051969

TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA by Ibl GmbH — Product Code CHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2005
Date Received
July 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic/Fluorometric Method, Catecholamines
Device Class
Class I
Regulation Number
862.1165
Review Panel
CH
Submission Type

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Other clearances for product code CHQ

  • K032199 — ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (January 30, 2004)
  • K972167 — PLASMA CATECHOLAMINE KIT (August 4, 1997)
  • K963938 — MODEL 5500 CEAS (December 26, 1996)
  • K952919 — URINARY METANEPHRINE KIT (September 6, 1995)
  • K943099 — URINARY CATECHOLAMINE KIT (October 7, 1994)
  • K931148 — MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (June 9, 1993)
  • K894966 — PLASMA CATECHOLAMINES BY HPLC (October 25, 1989)
  • K873371 — URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) (January 5, 1988)
  • K855214 — CAT-3 CATECHOLAMINE ASSAY KIT (March 14, 1986)