Cleared Traditional

K801956 - TISSUE-TEK III TISSUE EMBEDDING CENTER (FDA 510(k) Clearance)

K801956 · Miles Laboratories, Inc. · Pathology device
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Sep 1980
Decision
29d
Days
-
Risk

K801956 is an FDA 510(k) clearance for the TISSUE-TEK III TISSUE EMBEDDING CENTER.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Pathology 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K801956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1980
Decision Date September 16, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 77d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -