Cleared Special

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION

K002528 · Sienco, Inc. · Hematology

Aug 2000

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K002528 is an FDA 510(k) clearance for the SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION, a Activated Whole Blood Clotting Time (Class II — Special Controls, product code JBP), submitted by Sienco, Inc. (Boulder, US). The FDA issued a Cleared decision on August 31, 2000, 15 days after receiving the submission on August 16, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7140.

Submission Details

510(k) Number	K002528 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2000
Decision Date	August 31, 2000
Days to Decision	15 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF