Cleared Traditional

K852889 - GENERAL DIAGNOSTICS RAPID E. COLI TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K852889 · Warner-Lambert Co. · Microbiology device
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Jul 1985
Decision
14d
Days
Class 1
Risk

K852889 is an FDA 510(k) clearance for the GENERAL DIAGNOSTICS RAPID E. COLI TEST. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on July 23, 1985 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Warner-Lambert Co. devices

Submission Details

510(k) Number K852889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date July 23, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.