Cleared Traditional

K933425 - AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 (FDA 510(k) Clearance)

Class I Chemistry device.

K933425 · Sigma Diagnostics, Inc. · Chemistry device
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Nov 1993
Decision
126d
Days
Class 1
Risk

K933425 is an FDA 510(k) clearance for the AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812. Classified as Alcohol Control Materials (product code DKC), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 16, 1993 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K933425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1993
Decision Date November 16, 1993
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 88d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DKC Alcohol Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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.