Product code LEQ— Clinical Chemistry

COULOCHEM II

Classification name: Detectors, Electrochemical, Liquid Chromatography
Device class: Class 1
Regulation: 21 CFR 862.2260
Advisory panel: Clinical Chemistry
Total cleared: 4
First cleared: 1980-07-21
Most recent: 1996-07-22

Market context for product code LEQ

FDA has cleared 4 devices under product code LEQ between 1980 and 1996, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19961 clearance
19901 clearance
19871 clearance
19801 clearance

Top applicants under product code LEQ

Esa, Inc.2 clearances
Waters Corporation1 clearance
Environmental Sciences Assoc., Inc.1 clearance

Recent clearances under product code LEQ

K962574 — WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)Waters Corporation·1996-07-22
K903231 — COULOCHEM IIEsa, Inc.·1990-09-27
K864729 — NEUROCHEMICAL ANALYZEREsa, Inc.·1987-04-13
K801439 — MODEL 5100 ELECTROCHEMICAL DETECTOREnvironmental Sciences Assoc., Inc.·1980-07-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.