Cleared Traditional

SABOURAUD DEXTROSE AGAR (K864250) - FDA 510(k) Clearance

Class I Microbiology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 306
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K864250.
GBNA MEDIUM
K871786 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
MRS AGAR AND MRS BROTH
K871702 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
MCBRIDE AGAR, MODIFIED
K871357 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
ANAEROBIC PEA BLOOD AGAR
K871090 · bioMerieux, Inc. · Apr 1987
BACTEROIDES BILE ESCULIN AGAR
K871091 · bioMerieux, Inc. · Apr 1987
CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)
K871093 · bioMerieux, Inc. · Apr 1987