Cleared Traditional

K872465 - DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME) (FDA 510(k) Clearance)

Class I Microbiology device.

K872465 · J R Scientific · Microbiology device
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Jul 1987
Decision
16d
Days
Class 1
Risk

K872465 is an FDA 510(k) clearance for the DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME). Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by J R Scientific (Woodland, US). The FDA issued a Cleared decision on July 9, 1987 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2220 - 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 J R Scientific devices

Submission Details

510(k) Number K872465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1987
Decision Date July 09, 1987
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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.