Cleared Traditional

K830506 - SYSMEX CC-150

K830506 is the FDA 510(k) clearance for SYSMEX CC-150 by Toa Medical Electronics USA, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K830506 · Toa Medical Electronics USA, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
81d
Days
Class 2
Risk

K830506 is an FDA 510(k) clearance for the SYSMEX CC-150. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Walker, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Toa Medical Electronics USA, Inc. devices

Submission Details

510(k) Number K830506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1983
Decision Date May 09, 1983
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 53
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K830506.
RDW PARAMETER FOR THE TECHNICON H6000
K834026 · Technicon Instruments Corp. · Jan 1984
TECHNICON H6000 SYSTEM
K832627 · Technicon Instruments Corp. · Sep 1983
FACS ANALYZER
K832420 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
QBC CENTRIFUGAL HEMATOLOGY SYS
K830451 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1983
PROFILE 750 BLOOD CELL COUNTER
K823886 · Mallinckrodt Critical Care · Mar 1983
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978 · Technicon Instruments Corp. · Aug 1981