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510(k) K894966

PLASMA CATECHOLAMINES BY HPLC by Bio-Rad — Product Code CHQ

K894966 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "PLASMA CATECHOLAMINES BY HPLC". The FDA issued a decision of Substantially Equivalent on October 25, 1989. The device falls under product code CHQ (Chromatographic/Fluorometric Method, Catecholamines), a Class I device regulated under 21 CFR 862.1165. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1989
Date Received
August 7, 1989
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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  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code CHQ

  • K051969 — TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENAL (October 3, 2005)
  • 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)
  • K873371 — URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) (January 5, 1988)
  • K855214 — CAT-3 CATECHOLAMINE ASSAY KIT (March 14, 1986)

FDA data resources