Cleared Traditional

DIMERTEST

K080069 · American Diagnostica, Inc. · Hematology

Feb 2008

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K080069 is an FDA 510(k) clearance for the DIMERTEST, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by American Diagnostica, Inc. (Stamford, US). The FDA issued a Cleared decision on February 13, 2008, 34 days after receiving the submission on January 10, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K080069 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2008
Decision Date	February 13, 2008
Days to Decision	34 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