Cleared Traditional

DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA

K935254 · American Diagnostica, Inc. · Hematology

Sep 1994

Decision

322d

Days

Class 2

Risk

About This 510(k) Submission

K935254 is an FDA 510(k) clearance for the DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA, a Plasma, Control, Normal (Class II — Special Controls, product code GIZ), submitted by American Diagnostica, Inc. (Greenwich, US). The FDA issued a Cleared decision on September 19, 1994, 322 days after receiving the submission on November 1, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K935254 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1993
Decision Date	September 19, 1994
Days to Decision	322 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement