Cleared Traditional

K853304 - 21 HEMATOLOGY REAGENTS

K853304 is the FDA 510(k) clearance for 21 HEMATOLOGY REAGENTS by In Vitro Diagnostics, Inc.. It is a Class 2 Hematology device (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

Submission Details

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.

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 207
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K853304.
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA
K853029 · Technicon Instruments Corp. · Jan 1986
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.
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QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K854242 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1986
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
QBC CENTRIFUGAL HEMATOLOGY ANALYZER
K844645 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1985