PURPLE/BLACK HEPARIN ASSAY CONTROL— 510(k) K042206

Name: FDA 510(k) clearance K042206
Creator: U.S. Food and Drug Administration
Published: 2004-10-18

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K042206 for PURPLE/BLACK HEPARIN ASSAY CONTROL, Substantially Equivalent on 2004-10-18. Applicant: Medtronic Vascular. Device class: 2.

Clearance details

Applicant: Medtronic Vascular
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2004-08-16
Decision date: 2004-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, 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.