Cleared Traditional

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

K003267 · Sigma Diagnostics, Inc. · Hematology

Mar 2001

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K003267 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A, 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 March 15, 2001, 148 days after receiving the submission on October 18, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K003267 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2000
Decision Date	March 15, 2001
Days to Decision	148 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