Cleared Traditional

K843485 - TRI-COUNT LASER

K843485 is the FDA 510(k) clearance for TRI-COUNT LASER by Hematology Marketing Assoc.. It is a Class 2 Hematology device (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

Submission Details

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.

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 K843485.
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
K850755 · R&D Systems, Inc. · May 1985
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K850250 · Technicon Instruments Corp. · Apr 1985
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K843805 · Coulter Electronics, Inc. · Dec 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · R&D Systems, Inc. · Nov 1984
RETIC-CHEX
K843093 · Streck Laboratories, Inc. · Oct 1984
PARA-TEK
K841531 · Streck Laboratories, Inc. · Jul 1984