Cleared Traditional

BUFFERED CHARCOAL YEAST EXTRACT AGAR (K802757) - FDA 510(k) Clearance

Class I Microbiology device.

K802757 · Remel Co. · Microbiology device
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Jan 1981
Decision
65d
Days
Class 1
Risk

K802757 is an FDA 510(k) clearance for the BUFFERED CHARCOAL YEAST EXTRACT AGAR. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1981 after a review of 65 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 Remel Co. devices

Submission Details

510(k) Number K802757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date January 08, 1981
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 102d · This submission: 65d
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 K802757.
GBNA MEDIUM
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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
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BACTEROIDES BILE ESCULIN AGAR
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CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)
K871093 · bioMerieux, Inc. · Apr 1987