IL TEST IMMUNOGLOBULIN M (IGM)— 510(k) K920008

Name: FDA 510(k) clearance K920008
Creator: U.S. Food and Drug Administration
Published: 1992-03-11

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K920008 for IL TEST IMMUNOGLOBULIN M (IGM), Substantially Equivalent on 1992-03-11. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code CGM
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1992-01-02
Decision date: 1992-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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