Cleared Traditional

K960005 - TRI-COURT 20-T
(FDA 510(k) Clearance)

K960005 · Hematronix, Inc. · Hematology

Mar 1996

Decision

77d

Days

Class 2

Risk

K960005 is an FDA 510(k) clearance for the TRI-COURT 20-T. This device is classified as a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK).

Submitted by Hematronix, Inc. (Benicia, US). The FDA issued a Cleared decision on March 19, 1996, 77 days after receiving the submission on January 2, 1996.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K960005 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 1996
Decision Date	March 19, 1996
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement