Cleared Traditional

K782128 - THERA CHEM

K782128 is an FDA 510(k) clearance for THERA CHEM, manufactured by Fisher Scientific Co., LLC. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K782128 · Fisher Scientific Co., LLC · Toxicology device
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Mar 1979
Decision
65d
Days
Class 1
Risk

K782128 is an FDA 510(k) clearance for the THERA CHEM. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on March 2, 1979 after a review of 65 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

FDA 510(k) Submission Details - K782128

510(k) Number K782128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date March 02, 1979
Days to Decision 65 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
22d faster than avg
Panel avg: 87d · This submission: 65d
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 K782128.
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL
K800886 · Utak Laboratories, Inc. · Apr 1980
HYPNOTICS PLUS SALICYLATE TX CONTROL
K800887 · Utak Laboratories, Inc. · Apr 1980
TRICYCLIC ANTIDEPRESSANT II TX CONTROL
K800889 · Utak Laboratories, Inc. · Apr 1980
SERUM, CONTROL, DRUGS, ANTIARRYTHMIC
K780960 · Vitek Systems, Inc. · Dec 1978