Cleared Traditional

K803128 - SERIES 810 PLATELET ANALYZER

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

K803128 · J.T. Baker Chemical Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 63
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K803128.
PROFILE 750 BLOOD CELL COUNTER
K823886 · Mallinckrodt Critical Care · Mar 1983
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
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