Cleared Traditional

K811084 - LABTRONIX PLATELET COUNTER(L/O/C.) (FDA 510(k) Clearance)

Class I Radiology device.

K811084 · Labtronix Corp. · Radiology device
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Jul 1981
Decision
93d
Days
Class 1
Risk

K811084 is an FDA 510(k) clearance for the LABTRONIX PLATELET COUNTER(L/O/C.). Classified as Platelet Counting, Manual (product code GLG), Class I - General Controls.

Submitted by Labtronix Corp. (Mchenry, US). The FDA issued a Cleared decision on July 23, 1981 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 864.6160 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Labtronix Corp. devices

Submission Details

510(k) Number K811084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date July 23, 1981
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GLG Platelet Counting, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.