Cleared Traditional

K050016 - HEMOCHRON SIGNATURE ELITE
(FDA 510(k) Clearance)

K050016 · International Technidyne Corp. · Hematology

Feb 2005

Decision

37d

Days

Class 2

Risk

K050016 is an FDA 510(k) clearance for the HEMOCHRON SIGNATURE ELITE. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA).

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on February 10, 2005, 37 days after receiving the submission on January 4, 2005.

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

Submission Details

510(k) Number	K050016 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 2005
Decision Date	February 10, 2005
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF