REVISED LABELING FOR ADX COCAINE METABOLITE— 510(k) K880009

Name: FDA 510(k) clearance K880009
Creator: U.S. Food and Drug Administration
Published: 1988-03-11

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K880009 for REVISED LABELING FOR ADX COCAINE METABOLITE, Substantially Equivalent on 1988-03-11. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1988-01-04
Decision date: 1988-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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