Cleared Special

K984141 - GBACT + KIT
(FDA 510(k) Clearance)

K984141 · Sienco, Inc. · Hematology

May 1999

Decision

191d

Days

Class 2

Risk

K984141 is an FDA 510(k) clearance for the GBACT + KIT, a Activated Whole Blood Clotting Time (Class II — Special Controls, product code JBP), submitted by Sienco, Inc. (Wheatridge, US). The FDA issued a Cleared decision on May 28, 1999, 191 days after receiving the submission on November 18, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7140.

Submission Details

510(k) Number	K984141 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 1998
Decision Date	May 28, 1999
Days to Decision	191 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF