Cleared Traditional

K761062 - HISTO-TEK W/ AUTOMATIC COVERSLIPPER

K761062 is an FDA 510(k) clearance for HISTO-TEK W/ AUTOMATIC COVERSLIPPER, manufactured by Miles Laboratories, Inc.. The device is a Class 1 Pathology device with product code IEO cleared through the Traditional 510(k) pathway after a 109-day FDA review.

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

FDA 510(k) Submission Details - K761062

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 77d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

IEO Device Classification - Class 1, General Controls

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.