Cleared Traditional

K983475 - HEMOCHRON RESPONSE

K983475 is an FDA 510(k) clearance for HEMOCHRON RESPONSE, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code KQG cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K983475 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
213d
Days
Class 2
Risk

K983475 is an FDA 510(k) clearance for the HEMOCHRON RESPONSE. Classified as Instrument, Coagulation (product code KQG), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on May 3, 1999 after a review of 213 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all International Technidyne Corp. devices

FDA 510(k) Submission Details - K983475

510(k) Number K983475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 113d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQG Device Classification - Class 2, Special Controls

Product Code KQG Instrument, Coagulation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KQG Instrument, Coagulation

Devices cleared under the same product code (KQG) and FDA review panel - the closest regulatory comparables to K983475.
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K791587 · Volu Sol Medical Industries · Sep 1979