DIMERTEST

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

AMERICAN DIAGNOSTICA, INC.

The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Dimertest.

Pre-market Notification Details

• Device ID: K080069
• 510k Number: K080069
• Device Name: DIMERTEST
• Classification: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
• Applicant: AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford, CT 06902
• Contact: Leigh Ayres
• Correspondent: Leigh Ayres; AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford, CT 06902
• Product Code: DAP
• CFR Regulation Number: 864.7320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-10
• Decision Date: 2008-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768003974	K080069	000
00842768003967	K080069	000