Cleared Traditional

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221

K013545 · Sigma Diagnostics, Inc. · Hematology

Nov 2001

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K013545 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 15, 2001, 22 days after receiving the submission on October 24, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K013545 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2001
Decision Date	November 15, 2001
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF

Device Classification

Product Code	DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.7320