Cleared Traditional

TIMENTIN 85MCG SENSITIVITY DISC (K852423) - FDA 510(k) Clearance

K852423 · Difco Laboratories, Inc. · Microbiology device
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Jul 1985
Decision
39d
Days
-
Risk

K852423 is an FDA 510(k) clearance for the TIMENTIN 85MCG SENSITIVITY DISC.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on July 16, 1985 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Microbiology 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K852423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1985
Decision Date July 16, 1985
Days to Decision 39 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 102d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -