Cleared Traditional

ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

K013318 · American Diagnostica, Inc. · Hematology
Mar 2002
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K013318 is an FDA 510(k) clearance for the ACTICHROME HEPARIN (ANTI-FXA), MODEL 832, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by American Diagnostica, Inc. (Greenwich, US). The FDA issued a Cleared decision on March 8, 2002, 154 days after receiving the submission on October 5, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K013318 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2001
Decision Date March 08, 2002
Days to Decision 154 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KFF — Assay, Heparin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7525

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