Cleared Traditional

K792032 - LEIF CENTRIFUGAL CYTOLOGY BUCKET (FDA 510(k) Clearance)

Class I Pathology device.

K792032 · Robert C. Leif, Ph.D. · Pathology device
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Nov 1979
Decision
51d
Days
Class 1
Risk

K792032 is an FDA 510(k) clearance for the LEIF CENTRIFUGAL CYTOLOGY BUCKET. Classified as Cytocentrifuge (product code IFB), Class I - General Controls.

Submitted by Robert C. Leif, Ph.D. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1979 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3300 - 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 Robert C. Leif, Ph.D. devices

Submission Details

510(k) Number K792032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1979
Decision Date November 30, 1979
Days to Decision 51 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 77d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IFB Cytocentrifuge
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3300
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.