Cleared Traditional

K960471 - TRI-COUNT 20
(FDA 510(k) Clearance)

K960471 · Hematronix, Inc. · Hematology

Mar 1996

Decision

48d

Days

Class 2

Risk

K960471 is an FDA 510(k) clearance for the TRI-COUNT 20, 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 20, 1996, 48 days after receiving the submission on February 1, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K960471 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 1996
Decision Date	March 20, 1996
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement