HEMOSIL LA POSITIVE CONTROL— 510(k) K102552

Name: FDA 510(k) clearance K102552
Creator: U.S. Food and Drug Administration
Published: 2011-04-05

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K102552 for HEMOSIL LA POSITIVE CONTROL, Substantially Equivalent on 2011-04-05. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2010-09-07
Decision date: 2011-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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