IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)— 510(k) K990302

Name: FDA 510(k) clearance K990302
Creator: U.S. Food and Drug Administration
Published: 1999-04-08

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K990302 for IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA), Substantially Equivalent on 1999-04-08. Applicant: Instrumentation Laboratory CO. Device class: 1.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GIR
Device class: Class 1
Regulation: 21 CFR 864.8950
Advisory panel: Hematology
Date received: 1999-02-01
Decision date: 1999-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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