Cleared Traditional

STA-CEPHASCREEN KIT

K053111 · Diagnostica Stago, Inc. · Hematology
May 2006
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K053111 is an FDA 510(k) clearance for the STA-CEPHASCREEN KIT, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on May 4, 2006, 181 days after receiving the submission on November 4, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K053111 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2005
Decision Date May 04, 2006
Days to Decision 181 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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