Cleared Traditional

K832535 - HEKTOEN ENTERIC AGAR PLATE

K832535 is the FDA 510(k) clearance for HEKTOEN ENTERIC AGAR PLATE by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K832535 · Otisville Biotech, Inc. · Microbiology device
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Oct 1983
Decision
67d
Days
Class 1
Risk

K832535 is an FDA 510(k) clearance for the HEKTOEN ENTERIC AGAR PLATE. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Walker, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 K832535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date October 04, 1983
Days to Decision 67 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
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 187
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