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510(k) K963938

MODEL 5500 CEAS by Esa, Inc. — Product Code CHQ

K963938 is an FDA 510(k) premarket notification submitted by Esa, Inc. for the device "MODEL 5500 CEAS". The FDA issued a decision of Substantially Equivalent on December 26, 1996. The device falls under product code CHQ (Chromatographic/Fluorometric Method, Catecholamines), a Class I device regulated under 21 CFR 862.1165. Esa, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1996
Date Received
October 1, 1996
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 Esa, Inc.

  • K032199 — ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (January 30, 2004)
  • K971640 — LEADCARE BLOOD LEAD TESTING SYSTEM (September 9, 1997)
  • K934977 — MODEL 5500 CEAS (January 11, 1994)
  • K931148 — MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (June 9, 1993)
  • K903231 — COULOCHEM II (September 27, 1990)
  • K864729 — NEUROCHEMICAL ANALYZER (April 13, 1987)

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)
  • 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