HEMOSIL SILICA CLOTTING TIME— 510(k) K050221

Name: FDA 510(k) clearance K050221
Creator: U.S. Food and Drug Administration
Published: 2005-03-30

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K050221 for HEMOSIL SILICA CLOTTING TIME, Substantially Equivalent on 2005-03-30. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2005-01-31
Decision date: 2005-03-30
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.