Cleared Traditional

K893682 - KIT- CIBA CORNING L-TDM I

K893682 is an FDA 510(k) clearance for KIT- CIBA CORNING L-TDM I, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Chemistry device with product code DIF cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K893682 · Ciba Corning Diagnostics Corp. · Chemistry device
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Sep 1989
Decision
135d
Days
Class 1
Risk

K893682 is an FDA 510(k) clearance for the KIT- CIBA CORNING L-TDM I, II, III. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 135 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K893682

510(k) Number K893682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1989
Decision Date September 28, 1989
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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 150
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K893682.
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM
K901271 · Bio-Rad · Apr 1990
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · Baxter Healthcare Corp · Feb 1990
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
K895816 · Bio-Rad · Dec 1989
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
K893835 · Ciba Corning Diagnostics Corp. · Jul 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
K890957 · Hycor Biomedical, Inc. · Mar 1989
DRUG CONTROL SET
K884178 · Gelman Sciences, Inc. · Feb 1989