Cleared Traditional

N-ASSAY TIA FIBRINOGEN TEST KIT

K965113 · Crestat Diagnostics, Inc. · Hematology

Apr 1997

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K965113 is an FDA 510(k) clearance for the N-ASSAY TIA FIBRINOGEN TEST KIT, a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on April 16, 1997, 117 days after receiving the submission on December 20, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number	K965113 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 1996
Decision Date	April 16, 1997
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement