Cleared Traditional

K843485 - TRI-COUNT LASER

K843485 is an FDA 510(k) clearance for TRI-COUNT LASER, manufactured by Hematology Marketing Assoc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K843485 · Hematology Marketing Assoc. · Hematology device
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Dec 1984
Decision
97d
Days
Class 2
Risk

K843485 is an FDA 510(k) clearance for the TRI-COUNT LASER. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Hematology Marketing Assoc. (Concord, US). The FDA issued a Cleared decision on December 12, 1984 after a review of 97 days - within the typical 510(k) review window.

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: 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 Hematology Marketing Assoc. devices

FDA 510(k) Submission Details - K843485

510(k) Number K843485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date December 12, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

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 167
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K843485.
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
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K843962 · R&D Systems, Inc. · Nov 1984
RETIC-CHEX
K843093 · Streck Laboratories, Inc. · Oct 1984