Cleared Traditional

K800888 - TRICYCLIC ANTIDEPRESSANTS I TX CONTROL

K800888 is an FDA 510(k) clearance for TRICYCLIC ANTIDEPRESSANTS I TX CONTROL, manufactured by Utak Laboratories, Inc.. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800888 · Utak Laboratories, Inc. · Toxicology device
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May 1980
Decision
15d
Days
Class 1
Risk

K800888 is an FDA 510(k) clearance for the TRICYCLIC ANTIDEPRESSANTS I TX CONTROL. 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 May 2, 1980 after a review of 15 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

FDA 510(k) Submission Details - K800888

510(k) Number K800888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1980
Decision Date May 02, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
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 175
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K800888.
BECKMAN ICS DRUG CONTROL SERA
K802854 · Beckman Instruments, Inc. · Dec 1980
IN VITRO DIAGNOSTIC STANDARDS
K802278 · Supelco, Inc. · Nov 1980
CARDIOACTIVE DRUGS CONTROL
K802672 · Fisher Scientific Co., LLC · Nov 1980
ANTICONVULSANTS TOXICOLOGY CONTROL
K800882 · Utak Laboratories, Inc. · Apr 1980
CARDIACS I TOXICOLOGY CONTROL
K800883 · Utak Laboratories, Inc. · Apr 1980
CARDIACS II TOXICOLOGY CONTROL
K800884 · Utak Laboratories, Inc. · Apr 1980