ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01— 510(k) K080696

Name: FDA 510(k) clearance K080696
Creator: U.S. Food and Drug Administration
Published: 2008-09-11

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K080696 for ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01, Substantially Equivalent on 2008-09-11. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DIP
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 2008-03-12
Decision date: 2008-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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