Cleared Traditional

KODATROL LIQUID CONTROL LEVELS I & II (K903189) - FDA 510(k) Clearance

Class I Chemistry device.

K903189 · Eastman Kodak Company · Chemistry device
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Aug 1990
Decision
34d
Days
Class 1
Risk

K903189 is an FDA 510(k) clearance for the KODATROL LIQUID CONTROL LEVELS I & II. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 34 days - a notably fast clearance cycle.

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: 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 Eastman Kodak Company devices

Submission Details

510(k) Number K903189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1990
Decision Date August 22, 1990
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture 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 - DIF Drug Mixture Control Materials

All 77
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K903189.
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
K914170 · Bio-Rad · Nov 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806 · Roche Diagnostic Systems, Inc. · Nov 1991
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
K911724 · E.I. Dupont DE Nemours & Co., Inc. · May 1991
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN
K901270 · Bio-Rad · May 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM
K901271 · Bio-Rad · Apr 1990
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · Baxter Healthcare Corp · Feb 1990