I-L TEST, DIRECT BILIRUBIN SET— 510(k) K850748

Name: FDA 510(k) clearance K850748
Creator: U.S. Food and Drug Administration
Published: 1985-04-03

Substantially Equivalent

Allied Instrumentation Laboratory

FDA 510(k) clearance K850748 for I-L TEST, DIRECT BILIRUBIN SET, Substantially Equivalent on 1985-04-03. Applicant: Allied Instrumentation Laboratory. Device class: 2.

Clearance details

Applicant: Allied Instrumentation Laboratory
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1985-02-25
Decision date: 1985-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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