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510(k) K864729

NEUROCHEMICAL ANALYZER by Esa, Inc. — Product Code LEQ

K864729 is an FDA 510(k) premarket notification submitted by Esa, Inc. for the device "NEUROCHEMICAL ANALYZER". The FDA issued a decision of Substantially Equivalent on April 13, 1987. The device falls under product code LEQ (Detectors, Electrochemical, Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Esa, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1987
Date Received
December 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detectors, Electrochemical, Liquid Chromatography
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
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)
  • K963938 — MODEL 5500 CEAS (December 26, 1996)
  • K934977 — MODEL 5500 CEAS (January 11, 1994)
  • K931148 — MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (June 9, 1993)
  • K903231 — COULOCHEM II (September 27, 1990)

Other clearances for product code LEQ

  • K962574 — WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) (July 22, 1996)
  • K903231 — COULOCHEM II (September 27, 1990)
  • K801439 — MODEL 5100 ELECTROCHEMICAL DETECTOR (July 21, 1980)

FDA data resources