Cleared Traditional

K864250 - SABOURAUD DEXTROSE AGAR

K864250 is an FDA 510(k) clearance for SABOURAUD DEXTROSE AGAR, manufactured by Mds Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JSJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K864250 · Mds Laboratories, Inc. · Microbiology device
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Mar 1987
Decision
154d
Days
Class 1
Risk

K864250 is an FDA 510(k) clearance for the SABOURAUD DEXTROSE AGAR. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987 after a review of 154 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mds Laboratories, Inc. devices

FDA 510(k) Submission Details - K864250

510(k) Number K864250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

JSJ Device Classification - Class 1, General Controls

Product Code JSJ Culture Media, Selective And Non-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 - JSJ Culture Media, Selective And Non-differential

All 271
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K864250.
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