Cleared Traditional

SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC (K850723) - FDA 510(k) Clearance

Class I Microbiology device.

K850723 · Rapid City Regional Hospital, Inc. · Microbiology device
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Mar 1985
Decision
28d
Days
Class 1
Risk

K850723 is an FDA 510(k) clearance for the SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Rapid City Regional Hospital, Inc. (Rapid City, US). The FDA issued a Cleared decision on March 22, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Rapid City Regional Hospital, Inc. devices

Submission Details

510(k) Number K850723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1985
Decision Date March 22, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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.

Regulatory Peers - JSI Culture Media, Selective And Differential

All 284
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