Cleared Traditional

K812081 - WAKO NEFA C TEST (FDA 510(k) Clearance)

Class I Chemistry device.

K812081 · Wako Chemicals USA, Inc. · Chemistry device
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Aug 1981
Decision
21d
Days
Class 1
Risk

K812081 is an FDA 510(k) clearance for the WAKO NEFA C TEST. Classified as Conversion To Ferric Hydroxymates (colorimetric), Fatty Acids (product code JLG), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Walker, US). The FDA issued a Cleared decision on August 12, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1290 - the FDA in vitro diagnostics and chemistry framework. 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K812081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1981
Decision Date August 12, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLG Conversion To Ferric Hydroxymates (colorimetric), Fatty Acids
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1290
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.