Cleared Special

HEMOCHRON RESPONSE/SYSTEM

K030818 · International Technidyne Corp. · Hematology
Apr 2003
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K030818 is an FDA 510(k) clearance for the HEMOCHRON RESPONSE/SYSTEM, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on April 2, 2003, 19 days after receiving the submission on March 14, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K030818 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2003
Decision Date April 02, 2003
Days to Decision 19 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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