COULOCHEM II— 510(k) K903231

Substantially Equivalent

Esa, Inc.

FDA 510(k) clearance K903231 for COULOCHEM II, Substantially Equivalent on 1990-09-27. Applicant: Esa, Inc.. Device class: 1.

Clearance details

Applicant: Esa, Inc.
Product code: Code LEQ
Device class: Class 1
Regulation: 21 CFR 862.2260
Advisory panel: Clinical Chemistry
Date received: 1990-07-23
Decision date: 1990-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LEQ

K962574 — WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)1996-07-22
K864729 — NEUROCHEMICAL ANALYZER1987-04-13
K801439 — MODEL 5100 ELECTROCHEMICAL DETECTOR1980-07-21

More clearances from Esa, Inc.

K032199 — ESA PLASMA FREE METANEPHRINE ANALYSIS KIT2004-01-30
K971640 — LEADCARE BLOOD LEAD TESTING SYSTEM1997-09-09
K963938 — MODEL 5500 CEAS1996-12-26
K934977 — MODEL 5500 CEAS1994-01-11
K931148 — MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM1993-06-09

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