ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER— 510(k) K853531

Name: FDA 510(k) clearance K853531
Creator: U.S. Food and Drug Administration
Published: 1985-09-04

Substantially Equivalent

American Dade

FDA 510(k) clearance K853531 for ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER, Substantially Equivalent on 1985-09-04. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1985-08-23
Decision date: 1985-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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