IL TEST PT FIBRINOGEN HS— 510(k) K923921

Name: FDA 510(k) clearance K923921
Creator: U.S. Food and Drug Administration
Published: 1992-10-26

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K923921 for IL TEST PT FIBRINOGEN HS, Substantially Equivalent on 1992-10-26. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GIS
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1992-08-05
Decision date: 1992-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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