HEMOSIL F11 & FV DNA CONTROL— 510(k) K093737

Name: FDA 510(k) clearance K093737
Creator: U.S. Food and Drug Administration
Published: 2010-05-04

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K093737 for HEMOSIL F11 & FV DNA CONTROL, Substantially Equivalent on 2010-05-04. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code NZB
Device class: Class 2
Regulation: 21 CFR 866.5910
Advisory panel: Microbiology
Date received: 2009-12-04
Decision date: 2010-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.