Cleared Traditional

DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR (K853336) - FDA 510(k) Clearance

Class I Microbiology device.

K853336 · Hardy Media · Microbiology device
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Aug 1985
Decision
20d
Days
Class 1
Risk

K853336 is an FDA 510(k) clearance for the DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 20 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

Submission Details

510(k) Number K853336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1985
Decision Date August 29, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 145
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K853336.
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CLED AGAR
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TRYCOPHYTON AGARS
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XANTHINE/TYROSINE/CASEIN AGAR
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BIRD SEED AGAR
K863573 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986