Cleared Traditional

VISIDEX II REAGENT STRIPS (K852747) - FDA 510(k) Clearance

K852747 · Miles Laboratories, Inc. · Chemistry device
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Aug 1985
Decision
46d
Days
-
Risk

K852747 is an FDA 510(k) clearance for the VISIDEX II REAGENT STRIPS.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry 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 K852747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1985
Decision Date August 12, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -