Cleared Traditional

ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM

K023561 · International Technidyne Corp. · Hematology
Jan 2003
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K023561 is an FDA 510(k) clearance for the ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on January 31, 2003, 100 days after receiving the submission on October 23, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K023561 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2002
Decision Date January 31, 2003
Days to Decision 100 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKR — System, Hemoglobin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5620