Cleared Special

HEMOSIL SYNTHASIL

K060688 · Instrumentation Laboratory CO · Hematology
Apr 2006
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K060688 is an FDA 510(k) clearance for the HEMOSIL SYNTHASIL, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on April 13, 2006, 29 days after receiving the submission on March 15, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K060688 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2006
Decision Date April 13, 2006
Days to Decision 29 days
Submission Type Special
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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