Cleared Traditional

K821606 - BILE ESCULIN AGAR

K821606 is an FDA 510(k) clearance for BILE ESCULIN AGAR, manufactured by Hardy Media. The device is a Class 1 Microbiology device with product code JSF cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K821606 · Hardy Media · Microbiology device
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Jul 1982
Decision
39d
Days
Class 1
Risk

K821606 is an FDA 510(k) clearance for the BILE ESCULIN AGAR. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Hardy Media (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982 after a review of 39 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 Hardy Media devices

FDA 510(k) Submission Details - K821606

510(k) Number K821606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1982
Decision Date July 06, 1982
Days to Decision 39 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
63d faster than avg
Panel avg: 102d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

JSF Device Classification - Class 1, General Controls

Product Code JSF Culture Media, Single Biochemical Test
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 - JSF Culture Media, Single Biochemical Test

All 62
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K821606.
BILE ESCULIN AZIDE BROTH
K821593 · Hardy Media · Jul 1982
UREA AGAR SLANT
K821594 · Hardy Media · Jul 1982
EGG YOLK AGAR (PLATE)
K821845 · Granite Diagnostics, Inc. · Jul 1982
#2008 SIMMONS CITRATE
K820809 · Biomedica, Inc. · Apr 1982
PYR BROTH
K820149 · Carr-Scarborough Microbiologicals, Inc. · Feb 1982
CEPH LACTAM DISK
K800287 · Remel Co. · Mar 1980