Cleared Traditional

HEMOCHRON RESPONSE

K983475 · International Technidyne Corp. · Hematology
May 1999
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K983475 is an FDA 510(k) clearance for the HEMOCHRON RESPONSE, a Instrument, Coagulation (Class II — Special Controls, product code KQG), submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on May 3, 1999, 213 days after receiving the submission on October 2, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K983475 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1998
Decision Date May 03, 1999
Days to Decision 213 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KQG — Instrument, Coagulation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5400

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