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510(k) K873371

URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) by Bio-Rad — Product Code CHQ

K873371 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)". The FDA issued a decision of Substantially Equivalent on January 5, 1988. 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
January 5, 1988
Date Received
August 21, 1987
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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  • 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)
  • K894966 — PLASMA CATECHOLAMINES BY HPLC (October 25, 1989)
  • K855214 — CAT-3 CATECHOLAMINE ASSAY KIT (March 14, 1986)

FDA data resources