MODEL 5100 ELECTROCHEMICAL DETECTOR— 510(k) K801439

Name: FDA 510(k) clearance K801439
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

Environmental Sciences Assoc., Inc.

FDA 510(k) clearance K801439 for MODEL 5100 ELECTROCHEMICAL DETECTOR, Substantially Equivalent on 1980-07-21. Applicant: Environmental Sciences Assoc., Inc.. Device class: 1.

Clearance details

Applicant: Environmental Sciences Assoc., Inc.
Product code: Code LEQ
Device class: Class 1
Regulation: 21 CFR 862.2260
Advisory panel: Clinical Chemistry
Date received: 1980-06-20
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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