Cleared Traditional

K850891 - DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT (FDA 510(k) Clearance)

Class I Microbiology device.

K850891 · Sigma Chemical Co. · Microbiology device
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Mar 1985
Decision
21d
Days
Class 1
Risk

K850891 is an FDA 510(k) clearance for the DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 21 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K850891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1985
Decision Date March 25, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
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.