Cleared Traditional

K852371 - CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY (FDA 510(k) Clearance)

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

K852371 · Abbott Diagnostics · Hematology device
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Sep 1985
Decision
105d
Days
Class 2
Risk

K852371 is an FDA 510(k) clearance for the CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on September 17, 1985 after a review of 105 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 Abbott Diagnostics devices

Submission Details

510(k) Number K852371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1985
Decision Date September 17, 1985
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 113d · This submission: 105d
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 378
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