ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33— 510(k) K081231

Name: FDA 510(k) clearance K081231
Creator: U.S. Food and Drug Administration
Published: 2008-09-26

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K081231 for ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33, Substantially Equivalent on 2008-09-26. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 2008-05-01
Decision date: 2008-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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