Cleared Traditional

K972359 - REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/M...

K972359 is an FDA 510(k) clearance for REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/M..., manufactured by Remel, L.P.. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K972359 · Remel, L.P. · Microbiology device
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Aug 1997
Decision
64d
Days
Class 2
Risk

K972359 is an FDA 510(k) clearance for the REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on August 28, 1997 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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, L.P. devices

FDA 510(k) Submission Details - K972359

510(k) Number K972359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date August 28, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 102d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JSO Device Classification - Class 2, Special Controls

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 33
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K972359.
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