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510(k) K894966

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

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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Other clearances for product code CHQ

  • K051969 — TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENAL (October 3, 2005)
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  • 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)