Cleared Traditional

K853722 - PLT-4 PLATELET ANALYZER

K853722 is the FDA 510(k) clearance for PLT-4 PLATELET ANALYZER by Texas Intl. Laboratories, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K853722 · Texas Intl. Laboratories, Inc. · Hematology device
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Jan 1986
Decision
134d
Days
Class 2
Risk

K853722 is an FDA 510(k) clearance for the PLT-4 PLATELET ANALYZER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Texas Intl. Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on January 17, 1986 after a review of 134 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 Texas Intl. Laboratories, Inc. devices

Submission Details

510(k) Number K853722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1985
Decision Date January 17, 1986
Days to Decision 134 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 113d · This submission: 134d
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 53
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K853722.
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K851943 · Coulter Electronics, Inc. · Aug 1985