Cleared Traditional

K761062 - HISTO-TEK W/ AUTOMATIC COVERSLIPPER (FDA 510(k) Clearance)

Class I Pathology device.

K761062 · Miles Laboratories, Inc. · Pathology device
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Mar 1977
Decision
109d
Days
Class 1
Risk

K761062 is an FDA 510(k) clearance for the HISTO-TEK W/ AUTOMATIC COVERSLIPPER. Classified as Processor, Tissue, Automated (product code IEO), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1977 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3875 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

Submission Details

510(k) Number K761062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1976
Decision Date March 07, 1977
Days to Decision 109 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 77d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IEO Processor, Tissue, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3875
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.