Cleared Traditional

K934273 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)

K934273 is an FDA 510(k) clearance for KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE..., manufactured by Eastman Kodak Company. The device is a Class 2 Toxicology device with product code DMT cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K934273 · Eastman Kodak Company · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
202d
Days
Class 2
Risk

K934273 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC). Classified as Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet (product code DMT), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 21, 1994 after a review of 202 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3040 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eastman Kodak Company devices

FDA 510(k) Submission Details - K934273

510(k) Number K934273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date March 21, 1994
Days to Decision 202 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 87d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DMT Device Classification - Class 2, Special Controls

Product Code DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

All 7
Devices cleared under the same product code (DMT) and FDA review panel - the closest regulatory comparables to K934273.
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
K000410 · Beckman Coulter, Inc. · Apr 2000
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
K971506 · Beckman Instruments, Inc. · Jun 1997
ETHYL ALCOHOL ASSAY
K923783 · Diagnostic Reagents, Inc. · Jan 1993
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
K864894 · Em Diagnostic Systems, Inc. · Jan 1987
ETHYL ALCOHOL ASSAY KIT
K843378 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
EMIT-ST SERUM ETHYL ALCOHOL ASSAY
K810467 · Syva Co. · Mar 1981