Cleared Traditional

K936028 - CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936028 · Microgenics Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
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
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.