Cleared Traditional

K965157 - CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 (FDA 510(k) Clearance)

Class I Toxicology device.

K965157 · Boehringer Mannheim Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
25d
Days
Class 1
Risk

K965157 is an FDA 510(k) clearance for the CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K965157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date January 17, 1997
Days to Decision 25 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
62d faster than avg
Panel avg: 87d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.