Cleared Traditional

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER (K913305) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913305 · Unipath , Ltd. · Hematology device
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Nov 1991
Decision
120d
Days
Class 2
Risk

K913305 is an FDA 510(k) clearance for the CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Unipath , Ltd. (Mountain View, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 120 days - within the typical 510(k) review window.

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 Unipath , Ltd. devices

Submission Details

510(k) Number K913305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date November 22, 1991
Days to Decision 120 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
7d slower than avg
Panel avg: 113d · This submission: 120d
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 379
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