Cleared Traditional

K945678 - DATACELL 18MS

K945678 is the FDA 510(k) clearance for DATACELL 18MS by Danam Electronics. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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 220
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