Cleared Traditional

TRI-COUNT 16

K902389 · Hematronix, Inc. · Hematology
Aug 1990
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K902389 is an FDA 510(k) clearance for the TRI-COUNT 16, a Control, Cell Counter, Normal And Abnormal (Class II — Special Controls, product code JCN), submitted by Hematronix, Inc. (Plano, US). The FDA issued a Cleared decision on August 22, 1990, 84 days after receiving the submission on May 30, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K902389 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 1990
Decision Date August 22, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JCN — Control, Cell Counter, Normal And Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625