Cleared Traditional

K761138 - FA TISSUE FIXATIVE & WASH SET (FDA 510(k) Clearance)

Class I Pathology device.

K761138 · Zeus Scientific, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1978
Decision
406d
Days
Class 1
Risk

K761138 is an FDA 510(k) clearance for the FA TISSUE FIXATIVE & WASH SET. Classified as Fixative, Alcohol Containing (product code LDZ), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 6, 1978 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Zeus Scientific, Inc. devices

Submission Details

510(k) Number K761138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1976
Decision Date January 06, 1978
Days to Decision 406 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
329d slower than avg
Panel avg: 77d · This submission: 406d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDZ Fixative, Alcohol Containing
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.