Not Cleared Post-NSE

DEN000008 - DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN000008 · Life Technologies, Inc. · Gastroenterology & Urology device
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Feb 2001
Decision
59d
Days
Class 2
Risk

DEN000008 is an FDA 510(k) submission (not cleared) for the DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM). Classified as Media, Culture, Ex Vivo, Tissue And Cell (product code NDS), Class II - Special Controls.

Submitted by Life Technologies, Inc. (Washington, US). The FDA issued a Not Cleared (DENG) decision on February 16, 2001 after a review of 59 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5885 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Life Technologies, Inc. devices

Submission Details

510(k) Number DEN000008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 19, 2000
Decision Date February 16, 2001
Days to Decision 59 days
Submission Type Post-NSE
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 130d · This submission: 59d
Pathway characteristics

Device Classification

Product Code NDS Media, Culture, Ex Vivo, Tissue And Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5885
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 Gastroenterology & Urology devices follow this clearance model.