Cleared Traditional

K952560 - SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER
(FDA 510(k) Clearance)

K952560 · Sienco, Inc. · Hematology

Sep 1995

Decision

95d

Days

Class 2

Risk

K952560 is an FDA 510(k) clearance for the SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA).

Submitted by Sienco, Inc. (Broomfield, US). The FDA issued a Cleared decision on September 5, 1995, 95 days after receiving the submission on June 2, 1995.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K952560 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1995
Decision Date	September 05, 1995
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF