HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls— 510(k) K153137

Name: FDA 510(k) clearance K153137
Creator: U.S. Food and Drug Administration
Published: 2016-07-08

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K153137 for HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls, Substantially Equivalent on 2016-07-08. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code LCO
Device class: Class 2
Regulation: 21 CFR 864.7695
Advisory panel: Hematology
Date received: 2015-10-30
Decision date: 2016-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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