Cleared Traditional

K853304 - 21 HEMATOLOGY REAGENTS

K853304 is an FDA 510(k) clearance for 21 HEMATOLOGY REAGENTS, manufactured by In Vitro Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K853304 · In Vitro Diagnostics, Inc. · Hematology device
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Nov 1985
Decision
99d
Days
Class 2
Risk

K853304 is an FDA 510(k) clearance for the 21 HEMATOLOGY REAGENTS. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by In Vitro Diagnostics, Inc. (Shelton, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 99 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 In Vitro Diagnostics, Inc. devices

FDA 510(k) Submission Details - K853304

510(k) Number K853304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date November 12, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 113d · This submission: 99d
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 305
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K853304.
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.
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K854368 · Abbott Diagnostics · Jan 1986
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
K852371 · Abbott Diagnostics · Sep 1985
SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS
K850354 · Toa Medical Electronics USA, Inc. · May 1985
SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -
K844910 · Toa Medical Electronics USA, Inc. · Apr 1985