Cleared Traditional

K833276 - DRUG STANDARDS

K833276 is the FDA 510(k) clearance for DRUG STANDARDS by Supelco, Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K833276 · Supelco, Inc. · Toxicology device
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Jan 1984
Decision
101d
Days
Class 2
Risk

K833276 is an FDA 510(k) clearance for the DRUG STANDARDS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Supelco, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 1, 1984 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Supelco, Inc. devices

Submission Details

510(k) Number K833276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1983
Decision Date January 01, 1984
Days to Decision 101 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 87d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DKB Calibrators, Drug Mixture

All 78
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K833276.
EMIT D.A.U. LOW & MED. CALIBRATORS B
K842816 · Syva Co. · Sep 1984
ACA BARBITURATES SCREEN/BENZODIAZEPIN
K842386 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
THERAPEUTIC DRUG CONTROL
K833761 · Icl Scientific · Jan 1984
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC
K823740 · Syva Co. · Jan 1983
EMIT ST URINE METHAGUALONE CALIBRATOR
K821767 · Syva Co. · Jun 1982
EMIT-ST URINE CALIBRATOR A (#3A319
K820461 · Syva Co. · Mar 1982