Cleared Traditional

K852603 - MCCOY'S 5A MEDIUM - POWDERED FORM (FDA 510(k) Clearance)

K852603 · Mediatech, Inc. · Pathology device
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Jul 1985
Decision
23d
Days
-
Risk

K852603 is an FDA 510(k) clearance for the MCCOY'S 5A MEDIUM - POWDERED FORM.

Submitted by Mediatech, Inc. (Herndon, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 23 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 Mediatech, Inc. devices

Submission Details

510(k) Number K852603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1985
Decision Date July 12, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 77d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -