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

Substantially Equivalent

Pentapharm , Ltd.

Clearance details

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

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