Cleared Traditional

K840071 - DNASE AGAR W/TOLUDINE BLUE PLATE

K840071 is the FDA 510(k) clearance for DNASE AGAR W/TOLUDINE BLUE PLATE by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K840071 · Otisville Biotech, Inc. · Microbiology device
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Feb 1984
Decision
25d
Days
Class 1
Risk

K840071 is an FDA 510(k) clearance for the DNASE AGAR W/TOLUDINE BLUE PLATE. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 25 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 Otisville Biotech, Inc. devices

Submission Details

510(k) Number K840071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1984
Decision Date February 03, 1984
Days to Decision 25 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
77d faster than avg
Panel avg: 102d · This submission: 25d
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 101
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K840071.
SIMMONS CITRATE AGAR
K844532 · bioMerieux, Inc. · Jan 1985
BIOTIS LOWENSTEIN-JENSEN MEDIA
K843769 · Otisville Biotech, Inc. · Oct 1984
BIOTIS SEVEN H 11 AGAR
K843771 · Otisville Biotech, Inc. · Oct 1984
ESCULIN AGAR PLATE
K840073 · Otisville Biotech, Inc. · Feb 1984
BILE ESCULIN AGAR PLATE
K840068 · Otisville Biotech, Inc. · Jan 1984
EGG YOLK AGAR PLATE
K840070 · Otisville Biotech, Inc. · Jan 1984