Cleared Traditional

PEFAKIT APC-R FACTOR V LEIDEN

K042762 · Pentapharm , Ltd. · Hematology
Dec 2004
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K042762 is an FDA 510(k) clearance for the PEFAKIT APC-R FACTOR V LEIDEN, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Pentapharm , Ltd. (Washington, US). The FDA issued a Cleared decision on December 22, 2004, 78 days after receiving the submission on October 5, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K042762 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2004
Decision Date December 22, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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