Cleared Traditional

K832189 - HEMOCHRON THROMBOCHRONOMETER

K832189 is an FDA 510(k) clearance for HEMOCHRON THROMBOCHRONOMETER, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K832189 · International Technidyne Corp. · Hematology device
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Oct 1983
Decision
98d
Days
Class 2
Risk

K832189 is an FDA 510(k) clearance for the HEMOCHRON THROMBOCHRONOMETER. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by International Technidyne Corp. (Walker, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - 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 - K832189

510(k) Number K832189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1983
Decision Date October 14, 1983
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBP Device Classification - Class 2, Special Controls

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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.