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510(k) K051969

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

K051969 is an FDA 510(k) premarket notification submitted by Ibl GmbH for the device "TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA". The FDA issued a decision of Substantially Equivalent on October 3, 2005. The device falls under product code CHQ (Chromatographic/Fluorometric Method, Catecholamines), a Class I device regulated under 21 CFR 862.1165. Ibl GmbH has at least 5 other 510(k) clearances on record.

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

Other clearances by Ibl GmbH

  • K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (September 24, 2004)
  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (July 22, 2004)
  • K033786 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIV (February 27, 2004)
  • K032796 — IBL C3D-CIC EIA TEST (January 13, 2004)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)

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)

FDA data resources