Cleared Traditional

K803128 - SERIES 810 PLATELET ANALYZER

K803128 is an FDA 510(k) clearance for SERIES 810 PLATELET ANALYZER, manufactured by J.T. Baker Chemical Co.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K803128 · J.T. Baker Chemical Co. · Hematology device
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Apr 1981
Decision
112d
Days
Class 2
Risk

K803128 is an FDA 510(k) clearance for the SERIES 810 PLATELET ANALYZER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by J.T. Baker Chemical Co. (Walker, US). The FDA issued a Cleared decision on April 3, 1981 after a review of 112 days - within the typical 510(k) review window.

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: 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 J.T. Baker Chemical Co. devices

FDA 510(k) Submission Details - K803128

510(k) Number K803128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1980
Decision Date April 03, 1981
Days to Decision 112 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 113d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K803128.
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
K822758 · Toa Medical Electronics USA, Inc. · Oct 1982
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978 · Technicon Instruments Corp. · Aug 1981
CELL DYN 800 HEMATOLOGY ANALYZER
K803218 · Abbott Diagnostics · Jun 1981
PLATELET COUNTING KIT
K802636 · Streck Laboratories, Inc. · Dec 1980
LEUKOCYTE VOL. ANALYSIS APPARATUS
K802208 · Coulter Electronics, Inc. · Sep 1980
TECHNICON H6000 HEMATOLOGY SYSTEM
K801155 · Technicon Instruments Corp. · Jun 1980