Cleared Traditional

K853615 - APL BILE ESCULIN/AZIDE AGAR

K853615 is an FDA 510(k) clearance for APL BILE ESCULIN/AZIDE AGAR, manufactured by Apl Medical Supplies. The device is a Class 1 Microbiology device with product code JSH cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K853615 · Apl Medical Supplies · Microbiology device
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Sep 1985
Decision
8d
Days
Class 1
Risk

K853615 is an FDA 510(k) clearance for the APL BILE ESCULIN/AZIDE AGAR. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Apl Medical Supplies (Las Vegas, US). The FDA issued a Cleared decision on September 6, 1985 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 Apl Medical Supplies devices

FDA 510(k) Submission Details - K853615

510(k) Number K853615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1985
Decision Date September 06, 1985
Days to Decision 8 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
94d faster than avg
Panel avg: 102d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

JSH Device Classification - Class 1, General Controls

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 118
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K853615.
APL DNASE TEST AGAR
K853612 · Apl Medical Supplies · Sep 1985
APL GN BROTH
K853613 · Apl Medical Supplies · Sep 1985
APL FLUID THIOGLYCOLLATE MEDIUM
K853614 · Apl Medical Supplies · Sep 1985
APL CHLAMYDOSPORE AGAR
K853616 · Apl Medical Supplies · Sep 1985
DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR
K853336 · Hardy Media · Aug 1985
CLED AGAR
K852578 · American Laboratory Supply, Inc. · Jul 1985