Cleared Traditional

K945678 - DATACELL 18MS

K945678 is an FDA 510(k) clearance for DATACELL 18MS, manufactured by Danam Electronics. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K945678 · Danam Electronics · Hematology device
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Sep 1995
Decision
298d
Days
Class 2
Risk

K945678 is an FDA 510(k) clearance for the DATACELL 18MS. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Danam Electronics (Dallas, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 298 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Danam Electronics devices

FDA 510(k) Submission Details - K945678

510(k) Number K945678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1994
Decision Date September 12, 1995
Days to Decision 298 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 113d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 316
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K945678.
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K952789 · Immunotech Corp. · Aug 1995