Cleared Traditional

K845019 - CELL-DYN 1000 AUTOMATED HEMATOLOGY ANAL...

K845019 is the FDA 510(k) clearance for CELL-DYN 1000 AUTOMATED HEMATOLOGY ANAL... by Abbott Diagnostics. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K845019 · Abbott Diagnostics · Hematology device
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Mar 1985
Decision
89d
Days
Class 2
Risk

K845019 is an FDA 510(k) clearance for the CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on March 26, 1985 after a review of 89 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 Abbott Diagnostics devices

Submission Details

510(k) Number K845019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date March 26, 1985
Days to Decision 89 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 113d · This submission: 89d
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 69
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K845019.
COULTER VOLUME ADAPTER
K851943 · Coulter Electronics, Inc. · Aug 1985
COULTER CHANNELYZER 256
K851736 · Coulter Electronics, Inc. · Jul 1985
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
K850171 · Toa Medical Electronics USA, Inc. · May 1985
COULTER COUNTER MODEL M4
K843303 · Coulter Electronics, Inc. · Dec 1984
COULTER COUNTER MODEL ZM
K843164 · Coulter Electronics, Inc. · Nov 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346 · Coulter Electronics, Inc. · Jul 1984