MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM— 510(k) K931148

Name: FDA 510(k) clearance K931148
Creator: U.S. Food and Drug Administration
Published: 1993-06-09

Substantially Equivalent

Esa, Inc.

FDA 510(k) clearance K931148 for MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM, Substantially Equivalent on 1993-06-09. Applicant: Esa, Inc.. Device class: 1.

Clearance details

Applicant: Esa, Inc.
Product code: Code CHQ
Device class: Class 1
Regulation: 21 CFR 862.1165
Advisory panel: Clinical Chemistry
Date received: 1993-03-05
Decision date: 1993-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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