Home / 510(k) Clearances / K903231

510(k) K903231

COULOCHEM II by Esa, Inc. — Product Code LEQ

K903231 is an FDA 510(k) premarket notification submitted by Esa, Inc. for the device "COULOCHEM II". The FDA issued a decision of Substantially Equivalent on September 27, 1990. 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
September 27, 1990
Date Received
July 23, 1990
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)
  • K864729 — NEUROCHEMICAL ANALYZER (April 13, 1987)

Other clearances for product code LEQ

  • K962574 — WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) (July 22, 1996)
  • K864729 — NEUROCHEMICAL ANALYZER (April 13, 1987)
  • K801439 — MODEL 5100 ELECTROCHEMICAL DETECTOR (July 21, 1980)

FDA data resources