ALCYON 300I (WITH ISE MODULE) ANALYZER— 510(k) K993083

Name: FDA 510(k) clearance K993083
Creator: U.S. Food and Drug Administration
Published: 1999-10-05

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K993083 for ALCYON 300I (WITH ISE MODULE) ANALYZER, Substantially Equivalent on 1999-10-05. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1999-09-15
Decision date: 1999-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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