Cleared Traditional

K936028 - CEDIA DAU BAR/BENZ 300

K936028 is the FDA 510(k) clearance for CEDIA DAU BAR/BENZ 300 by Microgenics Corp.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K936028 · Microgenics Corp. · Toxicology device

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Mar 1994

Decision

87d

Days

Class 2

Risk

K936028 is an FDA 510(k) clearance for the CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on March 14, 1994 after a review of 87 days - a notably fast clearance cycle.

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: 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 Microgenics Corp. devices

Submission Details

510(k) Number	K936028 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 1993
Decision Date	March 14, 1994
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

At panel average

Panel avg: 87d · This submission: 87d

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 77

Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K936028.

ROCHE AMMONIA (VARIOUS)

K942048 · Roche Diagnostic Systems, Inc. · Oct 1994

URINE CALIBRATOR

K940935 · Diagnostic Reagents, Inc. · Jul 1994

CEDIA DAU NEGATIVE CALIBRATOR

K935793 · Microgenics Corp. · Mar 1994

URINE CALIBRATORS AND CONTROLS MODIFICATION

K935101 · Diagnostic Reagents, Inc. · Jan 1994

CEDIA DAU 5-DRUG CALIBRATORS

K935792 · Microgenics Corp. · Jan 1994

CEDIA DAU 4-DRUG CUTOFF CALIBRATOR

K935794 · Microgenics Corp. · Jan 1994

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K936028

Microgenics Corp.

Concord, CA · US

BETSY SOARES-MADDOX

Regulatory profile

107 submissions 106 cleared

99% clearance rate · Active in Toxicology

Data Intelligence Layer

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