Cleared Traditional

K933425 - AMMONIA/ETHANOL CONTROLS

K933425 is the FDA 510(k) clearance for AMMONIA/ETHANOL CONTROLS by Sigma Diagnostics, Inc.. It is a Class 1 Chemistry device (product code DKC) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - DKC Alcohol Control Materials

Devices cleared under the same product code (DKC) and FDA review panel - the closest regulatory comparables to K933425.
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · Medical Analysis Systems, Inc. · Jul 2003
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
K932067 · Sigma Diagnostics, Inc. · Jun 1993
ETHANOL CONTROLS LOW & HIGH E5133/E5258
K843872 · Sigma Chemical Co. · Oct 1984
EMIT-ST ETHYL ALCOHOL SERUM CONTROLS
K810465 · Syva Co. · Mar 1981
EMIT-STM ETHYL ALCOHOL URINE CONTROLS
K802618 · Syva Co. · Oct 1980