Cleared Traditional

K833794 - LYPHOCHEK THERAPEUTIC DRUG CONTROL

K833794 is an FDA 510(k) clearance for LYPHOCHEK THERAPEUTIC DRUG CONTROL, manufactured by Bio-Rad. The device is a Class 1 Chemistry device with product code DIF cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K833794 · Bio-Rad · Chemistry device
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Jan 1984
Decision
84d
Days
Class 1
Risk

K833794 is an FDA 510(k) clearance for the LYPHOCHEK THERAPEUTIC DRUG CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on January 24, 1984 after a review of 84 days - a notably fast clearance cycle.

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: 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 Bio-Rad devices

FDA 510(k) Submission Details - K833794

510(k) Number K833794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1983
Decision Date January 24, 1984
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
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 K833794.
EMIT 700 CONTROL SET B
K843508 · Syva Co. · Sep 1984
EMIT 700 CONTROL SET A
K843161 · Syva Co. · Aug 1984
COMA TOXICOLOGY CONTROL
K841439 · American Dade · May 1984
TRICYCLIC ANTIDEPRESSANTS
K831736 · Utak Laboratories, Inc. · Jul 1983
AMOXAPINE 8-HYDRO-XYAMOXAPINE
K831734 · Utak Laboratories, Inc. · Jul 1983
FLURAZEPAM TOXICOLOGY CONTROL
K831741 · Utak Laboratories, Inc. · Jul 1983