HEMOSIL PROS— 510(k) K053499

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K053499 for HEMOSIL PROS, Substantially Equivalent on 2006-01-13. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2005-12-16
Decision date: 2006-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Orangeburg, NY, 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.