Cleared Traditional

ENOXAPARIN TEST CARD

K013305 · Cardiovascular Diagnostics, Inc. · Hematology
Aug 2002
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K013305 is an FDA 510(k) clearance for the ENOXAPARIN TEST CARD, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by Cardiovascular Diagnostics, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 23, 2002, 323 days after receiving the submission on October 4, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K013305 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2001
Decision Date August 23, 2002
Days to Decision 323 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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