ESCHWEILER COMBI-ANALYSER MTA-500— 510(k) K840961

Name: FDA 510(k) clearance K840961
Creator: U.S. Food and Drug Administration
Published: 1984-08-10

Substantially Equivalent

U.S. Science, Inc.

FDA 510(k) clearance K840961 for ESCHWEILER COMBI-ANALYSER MTA-500, Substantially Equivalent on 1984-08-10. Applicant: U.S. Science, Inc.. Device class: 2.

Clearance details

Applicant: U.S. Science, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1984-03-06
Decision date: 1984-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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