Cleared Traditional

K900455 - ZEFAZONE SUSCEPTIBILITY POWDER

K900455 is the FDA 510(k) clearance for ZEFAZONE SUSCEPTIBILITY POWDER by The Upjohn Co.. It is a Class 2 Microbiology device (product code LOP) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K900455 · The Upjohn Co. · Microbiology device
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Feb 1990
Decision
10d
Days
Class 2
Risk

K900455 is an FDA 510(k) clearance for the ZEFAZONE SUSCEPTIBILITY POWDER. Classified as Solution, Antimicrobial (product code LOP), Class II - Special Controls.

Submitted by The Upjohn Co. (Kalamazoo, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology 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 The Upjohn Co. devices

Submission Details

510(k) Number K900455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date February 09, 1990
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 102d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOP Solution, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 Microbiology devices follow this clearance model.