HemosIL Factor XII Deficient Plasma— 510(k) K180486

Name: FDA 510(k) clearance K180486
Creator: U.S. Food and Drug Administration
Published: 2018-03-22

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K180486 for HemosIL Factor XII Deficient Plasma, Substantially Equivalent on 2018-03-22. 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: 2018-02-23
Decision date: 2018-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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