Cleared Traditional

K833276 - DRUG STANDARDS

K833276 is an FDA 510(k) clearance for DRUG STANDARDS, manufactured by Supelco, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K833276

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
Combination Product No
PCCP Authorized No
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.

DKB Device Classification - Class 2, Special Controls

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 87
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