Cleared Traditional

HEMASTAIN WRIGHT STAIN (K760486) - FDA 510(k) Clearance

K760486 · Geometric Data, Div. Smithkline Corp. · Cardiovascular device
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Aug 1976
Decision
10d
Days
-
Risk

K760486 is an FDA 510(k) clearance for the HEMASTAIN WRIGHT STAIN.

Submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1976 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Geometric Data, Div. Smithkline Corp. devices

Submission Details

510(k) Number K760486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1976
Decision Date August 30, 1976
Days to Decision 10 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -