Cleared Traditional

TECHNICON H*2(TM) SYSTEM

K900593 · Technicon Instruments Corp. · Hematology
Mar 1990
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K900593 is an FDA 510(k) clearance for the TECHNICON H*2(TM) SYSTEM, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on March 14, 1990, 35 days after receiving the submission on February 7, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K900593 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1990
Decision Date March 14, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220