Cleared Traditional

K863920 - WAKO(TM) ZN TEST (FDA 510(k) Clearance)

K863920 · Wako Chemicals USA, Inc. · Chemistry device
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Sep 1987
Decision
343d
Days
-
Risk

K863920 is an FDA 510(k) clearance for the WAKO(TM) ZN TEST.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on September 16, 1987 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K863920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1986
Decision Date September 16, 1987
Days to Decision 343 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 88d · This submission: 343d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -