IL PHENOBARBITAL ASSAY SYSTEM— 510(k) K910355

Name: FDA 510(k) clearance K910355
Creator: U.S. Food and Drug Administration
Published: 1991-04-03

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K910355 for IL PHENOBARBITAL ASSAY SYSTEM, Substantially Equivalent on 1991-04-03. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1991-01-29
Decision date: 1991-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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