PEFAKIT APC-R FACTOR V LEIDEN CONTROLS— 510(k) K042760

Name: FDA 510(k) clearance K042760
Creator: U.S. Food and Drug Administration
Published: 2004-12-22

Substantially Equivalent

Pentapharm , Ltd.

FDA 510(k) clearance K042760 for PEFAKIT APC-R FACTOR V LEIDEN CONTROLS, Substantially Equivalent on 2004-12-22. Applicant: Pentapharm , Ltd.. Device class: 2.

Clearance details

Applicant: Pentapharm , Ltd.
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2004-10-05
Decision date: 2004-12-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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