HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM— 510(k) K110031

Name: FDA 510(k) clearance K110031
Creator: U.S. Food and Drug Administration
Published: 2011-08-24

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K110031 for HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM, Substantially Equivalent on 2011-08-24. 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: 2011-01-05
Decision date: 2011-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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