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

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Auto D-dimer Control, Level 3, Model A8221.

Pre-market Notification Details

• Device ID: K013545
• 510k Number: K013545
• Device Name: SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
• Classification: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
• Applicant: SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103
• Contact: William R Gilbert Ii
• Correspondent: William R Gilbert Ii; SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103
• Product Code: DAP
• CFR Regulation Number: 864.7320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-10-24
• Decision Date: 2001-11-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15391521420791	K013545	000