HEMOSIL PROTEIN C— 510(k) K062430

Name: FDA 510(k) clearance K062430
Creator: U.S. Food and Drug Administration
Published: 2006-09-01

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K062430 for HEMOSIL PROTEIN C, Substantially Equivalent on 2006-09-01. 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: 2006-08-21
Decision date: 2006-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, 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.