Cleared Traditional

N-ASSAY TIA ANTITHROMBIN III TEST KIT

K972257 · Crestat Diagnostics, Inc. · Hematology

Oct 1997

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K972257 is an FDA 510(k) clearance for the N-ASSAY TIA ANTITHROMBIN III TEST KIT, a Antigen, Antiserum, Control, Antithrombin Iii (Class II — Special Controls, product code DDQ), submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on October 20, 1997, 125 days after receiving the submission on June 17, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number	K972257 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 1997
Decision Date	October 20, 1997
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement