Cleared Traditional

K761001 - PAP-TRAY II (CATALOG #C600-2) (FDA 510(k) Clearance)

Class I Pathology device.

K761001 · Lerner Laboratories, Inc. · Pathology device
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Dec 1976
Decision
28d
Days
Class 1
Risk

K761001 is an FDA 510(k) clearance for the PAP-TRAY II (CATALOG #C600-2). Classified as Preservative, Cytological (product code LEA), Class I - General Controls.

Submitted by Lerner Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1976 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lerner Laboratories, Inc. devices

Submission Details

510(k) Number K761001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1976
Decision Date December 06, 1976
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 77d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LEA Preservative, Cytological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.