Cleared Traditional

ACTICHROME HEPARIN (ANTI-FIIA)

K013637 · American Diagnostica, Inc. · Hematology
Apr 2002
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K013637 is an FDA 510(k) clearance for the ACTICHROME HEPARIN (ANTI-FIIA), a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by American Diagnostica, Inc. (Greenwich, US). The FDA issued a Cleared decision on April 16, 2002, 162 days after receiving the submission on November 5, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K013637 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2001
Decision Date April 16, 2002
Days to Decision 162 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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