IL TEST 97573-15, PLASMINOGEN ASSAY— 510(k) K864212

Name: FDA 510(k) clearance K864212
Creator: U.S. Food and Drug Administration
Published: 1986-12-04

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K864212 for IL TEST 97573-15, PLASMINOGEN ASSAY, Substantially Equivalent on 1986-12-04. Applicant: Instrumentation Laboratory CO. Device class: 1.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code DDX
Device class: Class 1
Regulation: 21 CFR 866.5715
Advisory panel: Immunology
Date received: 1986-10-28
Decision date: 1986-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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