Cleared Traditional

K831734 - AMOXAPINE 8-HYDRO-XYAMOXAPINE

K831734 is the FDA 510(k) clearance for AMOXAPINE 8-HYDRO-XYAMOXAPINE by Utak Laboratories, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K831734 · Utak Laboratories, Inc. · Toxicology device
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Jul 1983
Decision
56d
Days
Class 1
Risk

K831734 is an FDA 510(k) clearance for the AMOXAPINE 8-HYDRO-XYAMOXAPINE. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Utak Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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: 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 Utak Laboratories, Inc. devices

Submission Details

510(k) Number K831734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1983
Decision Date July 26, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 87d · This submission: 56d
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 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K831734.
EMIT 700 CONTROL SET A
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LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794 · Bio-Rad · Jan 1984
TRI-LEVEL TDM CONTROL & I II III
K831500 · Ortho Diagnostic Systems, Inc. · Jun 1983
EMIT-ST PHOTOMETER & DILUTER VERIFICA
K830518 · Syva Co. · Apr 1983
ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG
K823746 · Syva Co. · Jan 1983