HEMOSIL FACTOR XI DEFICIENT PLASMA— 510(k) K030287

Name: FDA 510(k) clearance K030287
Creator: U.S. Food and Drug Administration
Published: 2003-03-19

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K030287 for HEMOSIL FACTOR XI DEFICIENT PLASMA, Substantially Equivalent on 2003-03-19. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2003-01-28
Decision date: 2003-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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