Cleared Traditional

ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (K962745) - FDA 510(k) Clearance

Class I Microbiology device.

K962745 · Prepared Media Laboratory, Inc. · Microbiology device
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Oct 1996
Decision
79d
Days
Class 1
Risk

K962745 is an FDA 510(k) clearance for the ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000). Classified as Culture Media, Propagating Transport (product code JSN), Class I - General Controls.

Submitted by Prepared Media Laboratory, Inc. (Portland, US). The FDA issued a Cleared decision on October 2, 1996 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Prepared Media Laboratory, Inc. devices

Submission Details

510(k) Number K962745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date October 02, 1996
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 102d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSN Culture Media, Propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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.