Cleared Traditional

K860919 - THERACHEM

K860919 is the FDA 510(k) clearance for THERACHEM by Fisher Scientific Co., LLC. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K860919 · Fisher Scientific Co., LLC · Toxicology device
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Apr 1986
Decision
31d
Days
Class 1
Risk

K860919 is an FDA 510(k) clearance for the THERACHEM, TDC THERAPEUTIC DRUG CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 31 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K860919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1986
Decision Date April 11, 1986
Days to Decision 31 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
56d faster than avg
Panel avg: 87d · This submission: 31d
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 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K860919.
TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG
K870586 · Medical Analysis Systems, Inc. · Apr 1987
QUANTIMETRIX DRUG FREE SERUM CONTROL
K863388 · Quantimetrix Corp. · Sep 1986
LYPHOCHEK URINE TOXICOLOGY CONTROL
K861970 · Bio-Rad · Aug 1986
THERAPEUTIC DRUG (TDM) CALIBRATOR
K860097 · Instrumentation Laboratory CO · Feb 1986
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL
K853933 · Quantimetrix Corp. · Oct 1985
LYPHOCHEK DRUG FREE SERUM(HUMAN)
K852414 · Bio-Rad · Jul 1985