IL SYSTEM 810, ACL AND THE REAGENT SETS— 510(k) K862301

Name: FDA 510(k) clearance K862301
Creator: U.S. Food and Drug Administration
Published: 1986-09-03

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K862301 for IL SYSTEM 810, ACL AND THE REAGENT SETS, Substantially Equivalent on 1986-09-03. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1986-06-17
Decision date: 1986-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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