Cleared Traditional

K834371 - TRI-COUNT 10

K834371 is the FDA 510(k) clearance for TRI-COUNT 10 by Hematology Marketing Assoc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K834371 · Hematology Marketing Assoc. · Hematology device
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Mar 1984
Decision
87d
Days
Class 2
Risk

K834371 is an FDA 510(k) clearance for the TRI-COUNT 10. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Hematology Marketing Assoc. (Walker, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hematology Marketing Assoc. devices

Submission Details

510(k) Number K834371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1983
Decision Date March 09, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 113d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 145
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K834371.
PARA 4
K842017 · Streck Laboratories, Inc. · Jun 1984
ASSIGNED VALUE FOR MEAN PLATELET
K841239 · Coulter Electronics, Inc. · May 1984
PLT - 4 PLATELET
K840302 · R&D Systems, Inc. · Mar 1984
HC PLUS
K833563 · Coulter Electronics, Inc. · Jan 1984
MSI-HC HEMATOLOGY CONTROL
K834043 · Medical Specialties, Inc. · Jan 1984
TECHNICON H6000 SYSTEM CONTROL
K831704 · Technicon Instruments Corp. · Jul 1983